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CFR sections cited by the FDA

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Continuing the CFR sections cited by the FDA list, 1000 records per page, after 114.83.

  1. 114.89§ 114.89 Deviations from scheduled processes.
  2. 117.10§ 117.10 Personnel.
  3. 117.110§ 117.110 Defect action levels.
  4. 117.110(b)§ 117.110 Defect action levels.
  5. 117.126(a)(1)§ 117.126 Food safety plan.
  6. 117.126(a)(2)§ 117.126 Food safety plan.
  7. 117.130(a)(1)§ 117.130 Hazard analysis.
  8. 117.130(a)(2)§ 117.130 Hazard analysis.
  9. 117.135(a)(1)§ 117.135 Preventive controls.
  10. 117.135(b)§ 117.135 Preventive controls.
  11. 117.135(c)(1)§ 117.135 Preventive controls.
  12. 117.135(c)(2)§ 117.135 Preventive controls.
  13. 117.135(c)(3)§ 117.135 Preventive controls.
  14. 117.135(c)(6)§ 117.135 Preventive controls.
  15. 117.136(a)(2)§ 117.136 Circumstances in which the owner, operator, or agent in charge of a…
  16. 117.136(a)(2)(i)§ 117.136 Circumstances in which the owner, operator, or agent in charge of a…
  17. 117.139(a)§ 117.139 Recall plan.
  18. 117.139(b)§ 117.139 Recall plan.
  19. 117.145(a)§ 117.145 Monitoring.
  20. 117.145(b)§ 117.145 Monitoring.
  21. 117.145(c)(1)§ 117.145 Monitoring.
  22. 117.150(a)(1)§ 117.150 Corrective actions and corrections.
  23. 117.150(a)(2)§ 117.150 Corrective actions and corrections.
  24. 117.150(b)(2)§ 117.150 Corrective actions and corrections.
  25. 117.150(d)§ 117.150 Corrective actions and corrections.
  26. 117.155(b)§ 117.155 Verification.
  27. 117.160(a)§ 117.160 Validation.
  28. 117.160(b)§ 117.160 Validation.
  29. 117.165(a)(4)§ 117.165 Verification of implementation and effectiveness.
  30. 117.165(b)§ 117.165 Verification of implementation and effectiveness.
  31. 117.170§ 117.170 Reanalysis.
  32. 117.170(d)§ 117.170 Reanalysis.
  33. 117.170(e)§ 117.170 Reanalysis.
  34. 117.180(d)§ 117.180 Requirements applicable to a preventive controls qualified individual and a…
  35. 117.190(a)§ 117.190 Implementation records required for this subpart.
  36. 117.201(a)§ 117.201 Modified requirements that apply to a qualified facility.
  37. 117.201(a)(2)(i)§ 117.201 Modified requirements that apply to a qualified facility.
  38. 117.206(a)§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of…
  39. 117.206(a)(1)§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of…
  40. 117.206(a)(5)§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of…
  41. 117.20(a)§ 117.20 Plant and grounds.
  42. 117.20(b)§ 117.20 Plant and grounds.
  43. 117.305§ 117.305 General requirements applying to records.
  44. 117.310§ 117.310 Additional requirements applying to the food safety plan.
  45. 117.315§ 117.315 Requirements for record retention.
  46. 117.320§ 117.320 Requirements for official review.
  47. 117.35(a)§ 117.35 Sanitary operations.
  48. 117.35(b)(1)§ 117.35 Sanitary operations.
  49. 117.35(b)(2)§ 117.35 Sanitary operations.
  50. 117.35(c)§ 117.35 Sanitary operations.
  51. 117.35(d)§ 117.35 Sanitary operations.
  52. 117.35(e)§ 117.35 Sanitary operations.
  53. 117.37§ 117.37 Sanitary facilities and controls.
  54. 117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
  55. 117.40§ 117.40 Equipment and utensils.
  56. 117.405(a)(1)§ 117.405 Requirement to establish and implement a supply-chain program.
  57. 117.405(c)§ 117.405 Requirement to establish and implement a supply-chain program.
  58. 117.40(e)§ 117.40 Equipment and utensils.
  59. 117.40(f)§ 117.40 Equipment and utensils.
  60. 117.40(g)§ 117.40 Equipment and utensils.
  61. 117.410(c)§ 117.410 General requirements applicable to a supply-chain program.
  62. 117.415(a)(1)§ 117.415 Responsibilities of the receiving facility.
  63. 117.415(a)(2)§ 117.415 Responsibilities of the receiving facility.
  64. 117.420(b)§ 117.420 Using approved suppliers.
  65. 117.435(b)§ 117.435 Onsite audit.
  66. 117.475(b)§ 117.475 Records documenting the supply-chain program.
  67. 117.475(c)§ 117.475 Records documenting the supply-chain program.
  68. 117.80(a)§ 117.80 Processes and controls.
  69. 117.80(a)(2)§ 117.80 Processes and controls.
  70. 117.80(a)(5)§ 117.80 Processes and controls.
  71. 117.80(b)(1)§ 117.80 Processes and controls.
  72. 117.80(b)(2)§ 117.80 Processes and controls.
  73. 117.80(b)(3)§ 117.80 Processes and controls.
  74. 117.80(b)(4)§ 117.80 Processes and controls.
  75. 117.80(b)(5)§ 117.80 Processes and controls.
  76. 117.80(b)(6)§ 117.80 Processes and controls.
  77. 117.80(b)(8)§ 117.80 Processes and controls.
  78. 117.80(c)§ 117.80 Processes and controls.
  79. 117.80(c)(8)§ 117.80 Processes and controls.
  80. 117.80(c)(9)§ 117.80 Processes and controls.
  81. 117.93§ 117.93 Warehousing and distribution.
  82. 117.95(a)§ 117.95 Holding and distribution of human food by-products for use as animal food.
  83. 117.95(a)(3)§ 117.95 Holding and distribution of human food by-products for use as animal food.
  84. 117.95(b)§ 117.95 Holding and distribution of human food by-products for use as animal food.
  85. 118.10(a)(1)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  86. 118.10(a)(2)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  87. 118.10(a)(3)(1)
  88. 118.10(a)(3)(i)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  89. 118.10(a)(3)(ii)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  90. 118.10(a)(3)(iii)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  91. 118.10(a)(3)(iv)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  92. 118.10(a)(3)(v)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  93. 118.10(a)(3)(vi)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  94. 118.10(a)(3)(vii)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  95. 118.10(a)(4)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  96. 118.10(b)(1)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  97. 118.10(b)(2)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  98. 118.10(b)(3)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  99. 118.10(b)(4)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  100. 118.10(c)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  101. 118.10(d)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  102. 118.10(e)§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.
  103. 118.11(a)§ 118.11 Registration requirements for shell egg producers covered by the requirements of…
  104. 118.11(b)(2)(vi)§ 118.11 Registration requirements for shell egg producers covered by the requirements of…
  105. 118.11(e)(2)§ 118.11 Registration requirements for shell egg producers covered by the requirements of…
  106. 118.11(f)§ 118.11 Registration requirements for shell egg producers covered by the requirements of…
  107. 118.12(b)§ 118.12 Enforcement and compliance.
  108. 118.4§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  109. 118.4(a)(1)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  110. 118.4(a)(2)(i)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  111. 118.4(b)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  112. 118.4(b)(1)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  113. 118.4(b)(2)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  114. 118.4(b)(3)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  115. 118.4(b)(4)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  116. 118.4(b)(5)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  117. 118.4(c)(1)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  118. 118.4(c)(2)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  119. 118.4(c)(3)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  120. 118.4(d)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  121. 118.4(e)§ 118.4 Salmonella Enteritidis (SE) prevention measures.
  122. 118.5(a)§ 118.5 Environmental testing for Salmonella Enteritidis (SE).
  123. 118.5(a)(1)§ 118.5 Environmental testing for Salmonella Enteritidis (SE).
  124. 118.5(a)(2)(i)§ 118.5 Environmental testing for Salmonella Enteritidis (SE).
  125. 118.5(b)§ 118.5 Environmental testing for Salmonella Enteritidis (SE).
  126. 118.5(b)(1)§ 118.5 Environmental testing for Salmonella Enteritidis (SE).
  127. 118.6(a)(2)§ 118.6 Egg testing for Salmonella Enteritidis (SE).
  128. 118.6(c)§ 118.6 Egg testing for Salmonella Enteritidis (SE).
  129. 118.6(d)§ 118.6 Egg testing for Salmonella Enteritidis (SE).
  130. 118.6(f)§ 118.6 Egg testing for Salmonella Enteritidis (SE).
  131. 118.7(a)§ 118.7 Sampling methodology for Salmonella Enteritidis (SE).
  132. 118.8(a)§ 118.8 Testing methodology for Salmonella Enteritidis (SE).
  133. 118.9§ 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan.
  134. 120.10(a)§ 120.10 Corrective actions.
  135. 120.10(b)§ 120.10 Corrective actions.
  136. 120.10(b)(2)§ 120.10 Corrective actions.
  137. 120.10(c)§ 120.10 Corrective actions.
  138. 120.11(a)§ 120.11 Verification and validation.
  139. 120.11(a)(1)§ 120.11 Verification and validation.
  140. 120.11(a)(1)(i)§ 120.11 Verification and validation.
  141. 120.11(a)(1)(iv)§ 120.11 Verification and validation.
  142. 120.11(a)(1)(iv)(A)§ 120.11 Verification and validation.
  143. 120.11(a)(1)(iv)(B)§ 120.11 Verification and validation.
  144. 120.11(a)(1)(iv)(C)§ 120.11 Verification and validation.
  145. 120.11(a)(2)§ 120.11 Verification and validation.
  146. 120.11(b)§ 120.11 Verification and validation.
  147. 120.12(a)§ 120.12 Records.
  148. 120.12(a)(4)§ 120.12 Records.
  149. 120.12(b)§ 120.12 Records.
  150. 120.12(b)(4)§ 120.12 Records.
  151. 120.12(c)§ 120.12 Records.
  152. 120.12(d)(1)§ 120.12 Records.
  153. 120.12(d)(2)§ 120.12 Records.
  154. 120.12(d)(3)§ 120.12 Records.
  155. 120.12(e)§ 120.12 Records.
  156. 120.12(g)§ 120.12 Records.
  157. 120.13(a)§ 120.13 Training.
  158. 120.14(a)§ 120.14 Application of requirements to imported products.
  159. 120.14(a)(2)§ 120.14 Application of requirements to imported products.
  160. 120.14(a)(2)(i)§ 120.14 Application of requirements to imported products.
  161. 120.14(a)(2)(ii)§ 120.14 Application of requirements to imported products.
  162. 120.14(c)§ 120.14 Application of requirements to imported products.
  163. 120.24(a)§ 120.24 Process controls.
  164. 120.24(b)§ 120.24 Process controls.
  165. 120.24(c)§ 120.24 Process controls.
  166. 120.25§ 120.25 Process verification for certain processors.
  167. 120.25(a)§ 120.25 Process verification for certain processors.
  168. 120.25(b)§ 120.25 Process verification for certain processors.
  169. 120.25(c)§ 120.25 Process verification for certain processors.
  170. 120.25(d)§ 120.25 Process verification for certain processors.
  171. 120.25(d)(1)§ 120.25 Process verification for certain processors.
  172. 120.25(e)§ 120.25 Process verification for certain processors.
  173. 120.25(e)(2)(ii)§ 120.25 Process verification for certain processors.
  174. 120.6(a)§ 120.6 Sanitation standard operating procedures.
  175. 120.6(b)§ 120.6 Sanitation standard operating procedures.
  176. 120.6(c)§ 120.6 Sanitation standard operating procedures.
  177. 120.7(a)§ 120.7 Hazard analysis.
  178. 120.7(a)(2)§ 120.7 Hazard analysis.
  179. 120.7(b)§ 120.7 Hazard analysis.
  180. 120.7(c)§ 120.7 Hazard analysis.
  181. 120.7(d)§ 120.7 Hazard analysis.
  182. 120.8(a)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  183. 120.8(b)(1)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  184. 120.8(b)(2)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  185. 120.8(b)(3)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  186. 120.8(b)(4)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  187. 120.8(b)(5)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  188. 120.8(b)(6)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  189. 120.8(b)(7)§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
  190. 121.126(a)§ 121.126 Food defense plan.
  191. 121.135(a)§ 121.135 Mitigation strategies for actionable process steps.
  192. 121.145(b)§ 121.145 Food defense corrective actions.
  193. 1.225
  194. 123.10§ 123.10 Training.
  195. 123.11(a)§ 123.11 Sanitation control procedures.
  196. 123.11(b)§ 123.11 Sanitation control procedures.
  197. 123.11(c)§ 123.11 Sanitation control procedures.
  198. 123.12(a)(2)§ 123.12 Special requirements for imported products.
  199. 123.12(b)§ 123.12 Special requirements for imported products.
  200. 123.12(c)§ 123.12 Special requirements for imported products.
  201. 123.12(d)§ 123.12 Special requirements for imported products.
  202. 123.16§ 123.16 Process controls.
  203. 123.28(a)§ 123.28 Source controls.
  204. 123.28(b)§ 123.28 Source controls.
  205. 123.28(c)§ 123.28 Source controls.
  206. 123.28(d)§ 123.28 Source controls.
  207. 1.234
  208. 123.6(a)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  209. 123.6(b)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  210. 123.6(c)(1)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  211. 123.6(c)(2)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  212. 123.6(c)(3)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  213. 123.6(c)(4)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  214. 123.6(c)(5)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  215. 123.6(c)(6)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  216. 123.6(c)(7)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  217. 123.6(d)§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
  218. 123.7(a)§ 123.7 Corrective actions.
  219. 123.7(c)§ 123.7 Corrective actions.
  220. 123.7(d)§ 123.7 Corrective actions.
  221. 123.8(a)§ 123.8 Verification.
  222. 123.8(a)(1)§ 123.8 Verification.
  223. 123.8(a)(2)§ 123.8 Verification.
  224. 123.8(a)(2)(ii)§ 123.8 Verification.
  225. 123.8(a)(3)§ 123.8 Verification.
  226. 123.8(a)(3)(i)§ 123.8 Verification.
  227. 123.8(a)(3)(ii)§ 123.8 Verification.
  228. 123.8(a)(3)(iii)§ 123.8 Verification.
  229. 123.8(b)§ 123.8 Verification.
  230. 123.8(c)§ 123.8 Verification.
  231. 123.8(d)§ 123.8 Verification.
  232. 123.9(a)§ 123.9 Records.
  233. 123.9(b)(1)§ 123.9 Records.
  234. 123.9(b)(2)§ 123.9 Records.
  235. 123.9(b)(3)§ 123.9 Records.
  236. 123.9(c)§ 123.9 Records.
  237. 123.9(f)§ 123.9 Records.
  238. 1240.60(a)§ 1240.60 Molluscan shellfish.
  239. 1240.60(b)§ 1240.60 Molluscan shellfish.
  240. 1240.61(a)§ 1240.61 Mandatory pasteurization for all milk and milk products in final package form…
  241. 1240.61(b)§ 1240.61 Mandatory pasteurization for all milk and milk products in final package form…
  242. 1240.62(b)§ 1240.62 Turtles intrastate and interstate requirements.
  243. 1240.62(c)(1)§ 1240.62 Turtles intrastate and interstate requirements.
  244. 1240.65§ 1240.65 Psittacine birds.
  245. 1240.80§ 1240.80 General requirements for water for drinking and culinary purposes.
  246. 1240.86§ 1240.86 Protection of pier water system.
  247. 1240.90(a)§ 1240.90 Approval of treatment aboard conveyances.
  248. 1240.90(c)§ 1240.90 Approval of treatment aboard conveyances.
  249. 1250.22§ 1250.22 General requirements.
  250. 1250.27§ 1250.27 Storage of perishables.
  251. 1250.28§ 1250.28 Source and handling of ice.
  252. 1250.30(a)§ 1250.30 Construction, maintenance and use of places where food is prepared, served, or…
  253. 1250.30(c)§ 1250.30 Construction, maintenance and use of places where food is prepared, served, or…
  254. 1250.30(d)§ 1250.30 Construction, maintenance and use of places where food is prepared, served, or…
  255. 1250.32(a)§ 1250.32 Food-handling operations.
  256. 1250.32(b)§ 1250.32 Food-handling operations.
  257. 1250.33(a)§ 1250.33 Utensils and equipment.
  258. 1250.33(b)§ 1250.33 Utensils and equipment.
  259. 1250.33(c)§ 1250.33 Utensils and equipment.
  260. 1250.34§ 1250.34 Refrigeration equipment.
  261. 1250.35(b)§ 1250.35 Health of persons handling food.
  262. 1250.38(a)§ 1250.38 Toilet and lavatory facilities for use of food-handling employees.
  263. 1250.38(b)§ 1250.38 Toilet and lavatory facilities for use of food-handling employees.
  264. 1250.38(c)§ 1250.38 Toilet and lavatory facilities for use of food-handling employees.
  265. 1250.39§ 1250.39 Garbage equipment and disposition.
  266. 1250.41§ 1250.41 Submittal of construction plans.
  267. 1250.42(a)§ 1250.42 Water systems; constant temperature bottles.
  268. 1250.42(b)§ 1250.42 Water systems; constant temperature bottles.
  269. 1250.42(d)§ 1250.42 Water systems; constant temperature bottles.
  270. 1250.42(e)§ 1250.42 Water systems; constant temperature bottles.
  271. 1250.45(a)§ 1250.45 Food handling facilities on railroad conveyances.
  272. 1250.49§ 1250.49 Cleanliness of conveyances.
  273. 1250.50§ 1250.50 Toilet and lavatory facilities.
  274. 1250.53§ 1250.53 Discharge of wastes on air conveyances.
  275. 1250.62§ 1250.62 Submittal of construction plans.
  276. 1250.63§ 1250.63 General requirements.
  277. 1250.65§ 1250.65 Drainage.
  278. 1250.67§ 1250.67 Watering equipment.
  279. 1250.70(a)§ 1250.70 Employee conveniences.
  280. 1250.75(a)§ 1250.75 Disposal of human wastes.
  281. 1250.75(b)§ 1250.75 Disposal of human wastes.
  282. 1250.75(c)§ 1250.75 Disposal of human wastes.
  283. 1250.79(a)§ 1250.79 Garbage disposal.
  284. 1250.79(b)§ 1250.79 Garbage disposal.
  285. 1250.79(c)§ 1250.79 Garbage disposal.
  286. 1250.82(a)§ 1250.82 Potable water systems.
  287. 1250.82(b)§ 1250.82 Potable water systems.
  288. 1250.82(c)§ 1250.82 Potable water systems.
  289. 1250.82(d)§ 1250.82 Potable water systems.
  290. 1250.82(e)§ 1250.82 Potable water systems.
  291. 1250.82(f)§ 1250.82 Potable water systems.
  292. 1250.87§ 1250.87 Wash water.
  293. 1250.89(b)§ 1250.89 Swimming pools.
  294. 1250.90§ 1250.90 Toilets and lavatories.
  295. 1250.95§ 1250.95 Insect control.
  296. 1250.96§ 1250.96 Rodent control.
  297. 1270.21(a)
  298. 1270.21(d)
  299. 1270.21(e)
  300. 1270.21(f)
  301. 1270.21(h)(1)
  302. 1270.21(h)(2)
  303. 1270.31(a)
  304. 1270.31(b)
  305. 1270.31(c)
  306. 1270.31(d)
  307. 1270.33(a)
  308. 1270.33(b)
  309. 1270.33(c)
  310. 1270.33(d)
  311. 1270.33(e)
  312. 1270.33(f)
  313. 1270.33(h)
  314. 1270.35(a)
  315. 1270.35(c)
  316. 1270.35(d)
  317. 1271.150(c)(1)(iii)§ 1271.150 Current good tissue practice requirements.
  318. 1271.150(c)(2)§ 1271.150 Current good tissue practice requirements.
  319. 1271.155(e)§ 1271.155 Exemptions and alternatives.
  320. 1271.160(a)§ 1271.160 Establishment and maintenance of a quality program.
  321. 1271.160(b)(1)§ 1271.160 Establishment and maintenance of a quality program.
  322. 1271.160(b)(2)§ 1271.160 Establishment and maintenance of a quality program.
  323. 1271.160(b)(2)(i)§ 1271.160 Establishment and maintenance of a quality program.
  324. 1271.160(b)(2)(ii)§ 1271.160 Establishment and maintenance of a quality program.
  325. 1271.160(b)(2)(iii)§ 1271.160 Establishment and maintenance of a quality program.
  326. 1271.160(b)(3)§ 1271.160 Establishment and maintenance of a quality program.
  327. 1271.160(b)(4)§ 1271.160 Establishment and maintenance of a quality program.
  328. 1271.160(b)(5)§ 1271.160 Establishment and maintenance of a quality program.
  329. 1271.160(b)(6)§ 1271.160 Establishment and maintenance of a quality program.
  330. 1271.160(c)§ 1271.160 Establishment and maintenance of a quality program.
  331. 1271.160(d)§ 1271.160 Establishment and maintenance of a quality program.
  332. 1271.170(a)§ 1271.170 Personnel.
  333. 1271.170(b)§ 1271.170 Personnel.
  334. 1271.170(c)§ 1271.170 Personnel.
  335. 1271.180(a)§ 1271.180 Procedures.
  336. 1271.180(b)§ 1271.180 Procedures.
  337. 1271.180(c)§ 1271.180 Procedures.
  338. 1271.180(d)§ 1271.180 Procedures.
  339. 1271.190(a)§ 1271.190 Facilities.
  340. 1271.190(b)(1)§ 1271.190 Facilities.
  341. 1271.190(b)(2)§ 1271.190 Facilities.
  342. 1271.190(c)§ 1271.190 Facilities.
  343. 1271.190(d)(1)§ 1271.190 Facilities.
  344. 1271.190(d)(2)§ 1271.190 Facilities.
  345. 1271.195(a)§ 1271.195 Environmental control and monitoring.
  346. 1271.195(a)(1)§ 1271.195 Environmental control and monitoring.
  347. 1271.195(a)(2)§ 1271.195 Environmental control and monitoring.
  348. 1271.195(a)(3)§ 1271.195 Environmental control and monitoring.
  349. 1271.195(b)§ 1271.195 Environmental control and monitoring.
  350. 1271.195(c)§ 1271.195 Environmental control and monitoring.
  351. 1271.195(d)§ 1271.195 Environmental control and monitoring.
  352. 1271.200(a)§ 1271.200 Equipment.
  353. 1271.200(b)§ 1271.200 Equipment.
  354. 1271.200(c)§ 1271.200 Equipment.
  355. 1271.200(d)§ 1271.200 Equipment.
  356. 1271.200(e)§ 1271.200 Equipment.
  357. 1271.210(a)§ 1271.210 Supplies and reagents.
  358. 1271.210(b)§ 1271.210 Supplies and reagents.
  359. 1271.210(c)§ 1271.210 Supplies and reagents.
  360. 1271.210(d)(1)§ 1271.210 Supplies and reagents.
  361. 1271.210(d)(2)§ 1271.210 Supplies and reagents.
  362. 1271.210(d)(3)§ 1271.210 Supplies and reagents.
  363. 1271.215§ 1271.215 Recovery.
  364. 1271.220(a)§ 1271.220 Processing and process controls.
  365. 1271.220(b)§ 1271.220 Processing and process controls.
  366. 1271.220(c)§ 1271.220 Processing and process controls.
  367. 1271.225§ 1271.225 Process changes.
  368. 1271.230(a)§ 1271.230 Process validation.
  369. 1271.230(b)§ 1271.230 Process validation.
  370. 1271.230(c)§ 1271.230 Process validation.
  371. 1271.250(a)§ 1271.250 Labeling controls.
  372. 1271.250(b)§ 1271.250 Labeling controls.
  373. 1271.250(c)§ 1271.250 Labeling controls.
  374. 1271.260(a)§ 1271.260 Storage.
  375. 1271.260(b)§ 1271.260 Storage.
  376. 1271.260(c)§ 1271.260 Storage.
  377. 1271.260(d)§ 1271.260 Storage.
  378. 1271.260(e)§ 1271.260 Storage.
  379. 1271.265(a)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  380. 1271.265(b)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  381. 1271.265(c)(1)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  382. 1271.265(c)(2)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  383. 1271.265(c)(3)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  384. 1271.265(d)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  385. 1271.265(e)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  386. 1271.265(f)§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
  387. 1271.270(a)§ 1271.270 Records.
  388. 1271.270(b)§ 1271.270 Records.
  389. 1271.270(c)§ 1271.270 Records.
  390. 1271.270(d)§ 1271.270 Records.
  391. 1271.270(e)§ 1271.270 Records.
  392. 1271.290(a)§ 1271.290 Tracking.
  393. 1271.290(b)§ 1271.290 Tracking.
  394. 1271.290(c)§ 1271.290 Tracking.
  395. 1271.290(d)§ 1271.290 Tracking.
  396. 1271.290(e)§ 1271.290 Tracking.
  397. 1271.290(f)§ 1271.290 Tracking.
  398. 1271.320(a)§ 1271.320 Complaint file.
  399. 1271.320(b)§ 1271.320 Complaint file.
  400. 1271.320(c)§ 1271.320 Complaint file.
  401. 1271.350(a)(1)§ 1271.350 Reporting.
  402. 1271.350(a)(2)§ 1271.350 Reporting.
  403. 1271.350(b)(1)§ 1271.350 Reporting.
  404. 1271.350(b)(2)§ 1271.350 Reporting.
  405. 1271.350(b)(3)§ 1271.350 Reporting.
  406. 1271.370(a)§ 1271.370 Labeling.
  407. 1271.370(b)(1)§ 1271.370 Labeling.
  408. 1271.370(b)(3)§ 1271.370 Labeling.
  409. 1271.370(b)(4)§ 1271.370 Labeling.
  410. 1271.370(c)(1)§ 1271.370 Labeling.
  411. 1271.47(a)§ 1271.47 What procedures must I establish and maintain?
  412. 1271.47(b)§ 1271.47 What procedures must I establish and maintain?
  413. 1271.47(c)§ 1271.47 What procedures must I establish and maintain?
  414. 1271.47(d)§ 1271.47 What procedures must I establish and maintain?
  415. 1271.47(e)§ 1271.47 What procedures must I establish and maintain?
  416. 1271.50(a)§ 1271.50 How do I determine whether a donor is eligible?
  417. 1271.50(b)(1)§ 1271.50 How do I determine whether a donor is eligible?
  418. 1271.50(b)(2)§ 1271.50 How do I determine whether a donor is eligible?
  419. 1271.55(a)(1)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  420. 1271.55(a)(2)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  421. 1271.55(a)(3)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  422. 1271.55(b)(1)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  423. 1271.55(b)(2)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  424. 1271.55(b)(3)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  425. 1271.55(b)(4)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  426. 1271.55(c)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  427. 1271.55(d)(1)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  428. 1271.55(d)(1)(i)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  429. 1271.55(d)(1)(ii)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  430. 1271.55(d)(1)(iii)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  431. 1271.55(d)(2)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  432. 1271.55(d)(3)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  433. 1271.55(d)(4)§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination…
  434. 1271.60(a)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  435. 1271.60(b)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  436. 1271.60(c)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  437. 1271.60(c)(2)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  438. 1271.60(c)(3)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  439. 1271.60(d)(2)(ii)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  440. 1271.60(d)(4)§ 1271.60 What quarantine and other requirements apply before the donor-eligibility…
  441. 1271.65(a)§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses…
  442. 1271.65(b)(2)§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses…
  443. 1271.65(b)(3)§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses…
  444. 1271.65(c)§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses…
  445. 1271.75(a)(1)§ 1271.75 How do I screen a donor?
  446. 1271.75(a)(2)§ 1271.75 How do I screen a donor?
  447. 1271.75(b)§ 1271.75 How do I screen a donor?
  448. 1271.75(c)§ 1271.75 How do I screen a donor?
  449. 1271.75(d)§ 1271.75 How do I screen a donor?
  450. 1271.75(e)§ 1271.75 How do I screen a donor?
  451. 1271.80(a)§ 1271.80 What are the general requirements for donor testing?
  452. 1271.80(b)§ 1271.80 What are the general requirements for donor testing?
  453. 1271.80(c)§ 1271.80 What are the general requirements for donor testing?
  454. 1271.80(d)(1)§ 1271.80 What are the general requirements for donor testing?
  455. 1271.80(d)(2)§ 1271.80 What are the general requirements for donor testing?
  456. 1271.85(a)§ 1271.85 What donor testing is required for different types of cells and tissues?
  457. 1271.85(b)(1)§ 1271.85 What donor testing is required for different types of cells and tissues?
  458. 1271.85(b)(2)§ 1271.85 What donor testing is required for different types of cells and tissues?
  459. 1271.85(c)§ 1271.85 What donor testing is required for different types of cells and tissues?
  460. 1271.85(d)§ 1271.85 What donor testing is required for different types of cells and tissues?
  461. 1271.90(b)§ 1271.90 Are there other exceptions and what labeling requirements apply?
  462. 1271.90(b)(1)
  463. 1271.90(c)§ 1271.90 Are there other exceptions and what labeling requirements apply?
  464. 1271.90(c)(1)§ 1271.90 Are there other exceptions and what labeling requirements apply?
  465. 129.20(a)§ 129.20 Plant construction and design.
  466. 129.20(b)§ 129.20 Plant construction and design.
  467. 129.20(c)§ 129.20 Plant construction and design.
  468. 129.20(d)§ 129.20 Plant construction and design.
  469. 129.35(a)(1)§ 129.35 Sanitary facilities.
  470. 129.35(a)(2)§ 129.35 Sanitary facilities.
  471. 129.35(a)(3)(i)§ 129.35 Sanitary facilities.
  472. 129.35(a)(3)(ii)§ 129.35 Sanitary facilities.
  473. 129.35(a)(3)(iii)§ 129.35 Sanitary facilities.
  474. 129.35(a)(4)(i)§ 129.35 Sanitary facilities.
  475. 129.35(a)(4)(iii)§ 129.35 Sanitary facilities.
  476. 129.35(a)(4)(iv)§ 129.35 Sanitary facilities.
  477. 129.35(b)§ 129.35 Sanitary facilities.
  478. 129.35(c)§ 129.35 Sanitary facilities.
  479. 129.37(a)§ 129.37 Sanitary operations.
  480. 129.37(b)§ 129.37 Sanitary operations.
  481. 129.37(c)§ 129.37 Sanitary operations.
  482. 129.37(d)§ 129.37 Sanitary operations.
  483. 129.40(a)(1)§ 129.40 Equipment and procedures.
  484. 129.40(a)(2)§ 129.40 Equipment and procedures.
  485. 129.80(a)§ 129.80 Processes and controls.
  486. 129.80(b)(1)§ 129.80 Processes and controls.
  487. 129.80(c)§ 129.80 Processes and controls.
  488. 129.80(d)§ 129.80 Processes and controls.
  489. 129.80(e)§ 129.80 Processes and controls.
  490. 129.80(f)§ 129.80 Processes and controls.
  491. 129.80(g)(1)§ 129.80 Processes and controls.
  492. 129.80(g)(2)§ 129.80 Processes and controls.
  493. 129.80(g)(3)§ 129.80 Processes and controls.
  494. 129.80(h)§ 129.80 Processes and controls.
  495. 1.502(a)§ 1.502 What foreign supplier verification program (FSVP) must I have?
  496. 1.502(b)(1)§ 1.502 What foreign supplier verification program (FSVP) must I have?
  497. 1.503(a)§ 1.503 Who must develop my FSVP and perform FSVP activities?
  498. 1.504(a)§ 1.504 What hazard analysis must I conduct?
  499. 1.504(b)(1)§ 1.504 What hazard analysis must I conduct?
  500. 1.504(c)(1)§ 1.504 What hazard analysis must I conduct?
  501. 1.504(c)(2)§ 1.504 What hazard analysis must I conduct?
  502. 1.504(c)(3)§ 1.504 What hazard analysis must I conduct?
  503. 1.504(d)§ 1.504 What hazard analysis must I conduct?
  504. 1.504(e)§ 1.504 What hazard analysis must I conduct?
  505. 1.505(a)(2)§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
  506. 1.505(b)§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
  507. 1.505(c)(1)§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
  508. 1.505(c)(2)§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
  509. 1.505(d)§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?
  510. 1.506(a)(1)§ 1.506 What foreign supplier verification and related activities must I conduct?
  511. 1.506(a)(2)§ 1.506 What foreign supplier verification and related activities must I conduct?
  512. 1.506(b)§ 1.506 What foreign supplier verification and related activities must I conduct?
  513. 1.506(c)§ 1.506 What foreign supplier verification and related activities must I conduct?
  514. 1.506(d)(1)(i)§ 1.506 What foreign supplier verification and related activities must I conduct?
  515. 1.506(d)(1)(ii)§ 1.506 What foreign supplier verification and related activities must I conduct?
  516. 1.506(d)(2)§ 1.506 What foreign supplier verification and related activities must I conduct?
  517. 1.506(d)(3)§ 1.506 What foreign supplier verification and related activities must I conduct?
  518. 1.506(e)(1)§ 1.506 What foreign supplier verification and related activities must I conduct?
  519. 1.506(e)(1)(i)(B)§ 1.506 What foreign supplier verification and related activities must I conduct?
  520. 1.506(e)(1)(i)(D)§ 1.506 What foreign supplier verification and related activities must I conduct?
  521. 1.506(e)(1)(i)(E)§ 1.506 What foreign supplier verification and related activities must I conduct?
  522. 1.506(e)(1)(ii)§ 1.506 What foreign supplier verification and related activities must I conduct?
  523. 1.506(e)(1)(iii)§ 1.506 What foreign supplier verification and related activities must I conduct?
  524. 1.506(e)(1)(iv)(B)§ 1.506 What foreign supplier verification and related activities must I conduct?
  525. 1.506(e)(2)(ii)§ 1.506 What foreign supplier verification and related activities must I conduct?
  526. 1.506(e)(3)§ 1.506 What foreign supplier verification and related activities must I conduct?
  527. 1.507(a)§ 1.507 What requirements apply when I import a food that cannot be consumed without the…
  528. 1.507(a)(1)§ 1.507 What requirements apply when I import a food that cannot be consumed without the…
  529. 1.507(a)(2)(i)§ 1.507 What requirements apply when I import a food that cannot be consumed without the…
  530. 1.507(a)(2)(ii)§ 1.507 What requirements apply when I import a food that cannot be consumed without the…
  531. 1.507(a)(3)(i)§ 1.507 What requirements apply when I import a food that cannot be consumed without the…
  532. 1.508(a)§ 1.508 What corrective actions must I take under my FSVP?
  533. 1.508(b)§ 1.508 What corrective actions must I take under my FSVP?
  534. 1.509(a)§ 1.509 How must the importer be identified at entry?
  535. 1.509(b)§ 1.509 How must the importer be identified at entry?
  536. 1.510(a)(1)§ 1.510 How must I maintain records of my FSVP?
  537. 1.510(a)(2)§ 1.510 How must I maintain records of my FSVP?
  538. 1.510(b)(1)§ 1.510 How must I maintain records of my FSVP?
  539. 1.510(b)(3)§ 1.510 How must I maintain records of my FSVP?
  540. 1.510(c)(1)§ 1.510 How must I maintain records of my FSVP?
  541. 1.511(b)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  542. 1.511(c)(1)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  543. 1.511(c)(2)(i)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  544. 1.511(c)(2)(ii)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  545. 1.511(c)(3)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  546. 1.511(c)(4)(i)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  547. 1.511(c)(5)(i)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  548. 1.511(c)(5)(i)(A)(4)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  549. 1.511(c)(5)(i)(B)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  550. 1.511(c)(5)(i)(C)§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in…
  551. 1.512(b)(1)(i)(A)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  552. 1.512(b)(1)(ii)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  553. 1.512(b)(2)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  554. 1.512(b)(3)(i)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  555. 1.512(b)(3)(ii)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  556. 1.512(b)(3)(ii)(A)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  557. 1.512(b)(3)(iii)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  558. 1.512(b)(4)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  559. 1.512(b)(5)(i)(B)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  560. 1.512(b)(5)(ii)(A)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  561. 1.512(b)(5)(ii)(C)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  562. 1.512(b)(5)(iii)(B)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  563. 1.512(c)(1)(i)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  564. 1.512(c)(1)(iii)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  565. 1.512(c)(3)(i)§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food…
  566. 1.513(a)(1)§ 1.513 What FSVP may I have if I am importing certain food from a country with an…
  567. 1.513(b)(1)§ 1.513 What FSVP may I have if I am importing certain food from a country with an…
  568. 1.513(b)(2)§ 1.513 What FSVP may I have if I am importing certain food from a country with an…
  569. 1.908(a)(3)
  570. 1.908(a)(6)
  571. 1.908(b)
  572. 1.908(b)(2)
  573. 1.908(d)
  574. 1.908(e)(6)(iii)
  575. 211.100(a)§ 211.100 Written procedures; deviations.
  576. 211.100(b)§ 211.100 Written procedures; deviations.
  577. 211.101(a)§ 211.101 Charge-in of components.
  578. 211.101(b)§ 211.101 Charge-in of components.
  579. 211.101(b)(1)§ 211.101 Charge-in of components.
  580. 211.101(b)(3)§ 211.101 Charge-in of components.
  581. 211.101(b)(4)§ 211.101 Charge-in of components.
  582. 211.101(c)§ 211.101 Charge-in of components.
  583. 211.101(c)(1)§ 211.101 Charge-in of components.
  584. 211.101(c)(3)§ 211.101 Charge-in of components.
  585. 211.101(d)§ 211.101 Charge-in of components.
  586. 211.103§ 211.103 Calculation of yield.
  587. 211.105(a)§ 211.105 Equipment identification.
  588. 211.105(b)§ 211.105 Equipment identification.
  589. 211.110(a)§ 211.110 Sampling and testing of in-process materials and drug products.
  590. 211.110(a)(1)§ 211.110 Sampling and testing of in-process materials and drug products.
  591. 211.110(a)(3)§ 211.110 Sampling and testing of in-process materials and drug products.
  592. 211.110(a)(4)§ 211.110 Sampling and testing of in-process materials and drug products.
  593. 211.110(a)(5)§ 211.110 Sampling and testing of in-process materials and drug products.
  594. 211.110(b)§ 211.110 Sampling and testing of in-process materials and drug products.
  595. 211.110(c)§ 211.110 Sampling and testing of in-process materials and drug products.
  596. 211.110(d)§ 211.110 Sampling and testing of in-process materials and drug products.
  597. 211.111§ 211.111 Time limitations on production.
  598. 211.113(a)§ 211.113 Control of microbiological contamination.
  599. 211.113(b)§ 211.113 Control of microbiological contamination.
  600. 211.115(a)§ 211.115 Reprocessing.
  601. 211.115(b)§ 211.115 Reprocessing.
  602. 211.122(a)§ 211.122 Materials examination and usage criteria.
  603. 211.122(b)§ 211.122 Materials examination and usage criteria.
  604. 211.122(c)§ 211.122 Materials examination and usage criteria.
  605. 211.122(d)§ 211.122 Materials examination and usage criteria.
  606. 211.122(e)§ 211.122 Materials examination and usage criteria.
  607. 211.122(f)§ 211.122 Materials examination and usage criteria.
  608. 211.122(g)§ 211.122 Materials examination and usage criteria.
  609. 211.122(g)(2)§ 211.122 Materials examination and usage criteria.
  610. 211.122(g)(3)§ 211.122 Materials examination and usage criteria.
  611. 211.122(h)§ 211.122 Materials examination and usage criteria.
  612. 211.125(a)§ 211.125 Labeling issuance.
  613. 211.125(b)§ 211.125 Labeling issuance.
  614. 211.125(c)§ 211.125 Labeling issuance.
  615. 211.125(d)§ 211.125 Labeling issuance.
  616. 211.125(e)§ 211.125 Labeling issuance.
  617. 211.125(f)§ 211.125 Labeling issuance.
  618. 211.130§ 211.130 Packaging and labeling operations.
  619. 211.130(a)§ 211.130 Packaging and labeling operations.
  620. 211.130(b)§ 211.130 Packaging and labeling operations.
  621. 211.130(c)§ 211.130 Packaging and labeling operations.
  622. 211.130(d)§ 211.130 Packaging and labeling operations.
  623. 211.130(e)§ 211.130 Packaging and labeling operations.
  624. 211.132(b)§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug…
  625. 211.132(b)(1)§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug…
  626. 211.132(b)(2)§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug…
  627. 211.134(a)§ 211.134 Drug product inspection.
  628. 211.134(b)§ 211.134 Drug product inspection.
  629. 211.134(c)§ 211.134 Drug product inspection.
  630. 211.137(a)§ 211.137 Expiration dating.
  631. 211.137(b)§ 211.137 Expiration dating.
  632. 211.137(d)§ 211.137 Expiration dating.
  633. 211.142§ 211.142 Warehousing procedures.
  634. 211.142(a)§ 211.142 Warehousing procedures.
  635. 211.142(b)§ 211.142 Warehousing procedures.
  636. 211.150§ 211.150 Distribution procedures.
  637. 211.150(a)§ 211.150 Distribution procedures.
  638. 211.150(b)§ 211.150 Distribution procedures.
  639. 211.160(a)§ 211.160 General requirements.
  640. 211.160(b)§ 211.160 General requirements.
  641. 211.160(b)(1)§ 211.160 General requirements.
  642. 211.160(b)(2)§ 211.160 General requirements.
  643. 211.160(b)(3)§ 211.160 General requirements.
  644. 211.160(b)(4)§ 211.160 General requirements.
  645. 211.165(a)§ 211.165 Testing and release for distribution.
  646. 211.165(b)§ 211.165 Testing and release for distribution.
  647. 211.165(c)§ 211.165 Testing and release for distribution.
  648. 211.165(d)§ 211.165 Testing and release for distribution.
  649. 211.165(e)§ 211.165 Testing and release for distribution.
  650. 211.165(f)§ 211.165 Testing and release for distribution.
  651. 211.166(a)§ 211.166 Stability testing.
  652. 211.166(a)(1)§ 211.166 Stability testing.
  653. 211.166(a)(2)§ 211.166 Stability testing.
  654. 211.166(a)(3)§ 211.166 Stability testing.
  655. 211.166(a)(4)§ 211.166 Stability testing.
  656. 211.166(a)(5)§ 211.166 Stability testing.
  657. 211.166(b)§ 211.166 Stability testing.
  658. 211.166(c)(1)§ 211.166 Stability testing.
  659. 211.166(c)(2)§ 211.166 Stability testing.
  660. 211.167(a)§ 211.167 Special testing requirements.
  661. 211.167(b)§ 211.167 Special testing requirements.
  662. 211.167(c)§ 211.167 Special testing requirements.
  663. 211.170(a)§ 211.170 Reserve samples.
  664. 211.170(a)(1)§ 211.170 Reserve samples.
  665. 211.170(a)(3)§ 211.170 Reserve samples.
  666. 211.170(b)§ 211.170 Reserve samples.
  667. 211.170(b)(1)§ 211.170 Reserve samples.
  668. 211.170(b)(3)§ 211.170 Reserve samples.
  669. 211.173§ 211.173 Laboratory animals.
  670. 211.176§ 211.176 Penicillin contamination.
  671. 211.180(b)§ 211.180 General requirements.
  672. 211.180(c)§ 211.180 General requirements.
  673. 211.180(d)§ 211.180 General requirements.
  674. 211.180(e)§ 211.180 General requirements.
  675. 211.180(e)(1)§ 211.180 General requirements.
  676. 211.180(e)(2)§ 211.180 General requirements.
  677. 211.180(f)§ 211.180 General requirements.
  678. 211.182§ 211.182 Equipment cleaning and use log.
  679. 211.184(a)§ 211.184 Component, drug product container, closure, and labeling records.
  680. 211.184(b)§ 211.184 Component, drug product container, closure, and labeling records.
  681. 211.184(c)§ 211.184 Component, drug product container, closure, and labeling records.
  682. 211.184(d)§ 211.184 Component, drug product container, closure, and labeling records.
  683. 211.184(e)§ 211.184 Component, drug product container, closure, and labeling records.
  684. 211.186(a)§ 211.186 Master production and control records.
  685. 211.186(b)(1)§ 211.186 Master production and control records.
  686. 211.186(b)(2)§ 211.186 Master production and control records.
  687. 211.186(b)(3)§ 211.186 Master production and control records.
  688. 211.186(b)(4)§ 211.186 Master production and control records.
  689. 211.186(b)(5)§ 211.186 Master production and control records.
  690. 211.186(b)(6)§ 211.186 Master production and control records.
  691. 211.186(b)(7)§ 211.186 Master production and control records.
  692. 211.186(b)(8)§ 211.186 Master production and control records.
  693. 211.186(b)(9)§ 211.186 Master production and control records.
  694. 211.188§ 211.188 Batch production and control records.
  695. 211.188(a)§ 211.188 Batch production and control records.
  696. 211.188(b)§ 211.188 Batch production and control records.
  697. 211.188(b)(1)§ 211.188 Batch production and control records.
  698. 211.188(b)(10)§ 211.188 Batch production and control records.
  699. 211.188(b)(11)§ 211.188 Batch production and control records.
  700. 211.188(b)(12)§ 211.188 Batch production and control records.
  701. 211.188(b)(13)§ 211.188 Batch production and control records.
  702. 211.188(b)(2)§ 211.188 Batch production and control records.
  703. 211.188(b)(3)§ 211.188 Batch production and control records.
  704. 211.188(b)(4)§ 211.188 Batch production and control records.
  705. 211.188(b)(5)§ 211.188 Batch production and control records.
  706. 211.188(b)(6)§ 211.188 Batch production and control records.
  707. 211.188(b)(7)§ 211.188 Batch production and control records.
  708. 211.188(b)(8)§ 211.188 Batch production and control records.
  709. 211.188(b)(9)§ 211.188 Batch production and control records.
  710. 211.192§ 211.192 Production record review.
  711. 211.194(a)§ 211.194 Laboratory records.
  712. 211.194(a)(1)§ 211.194 Laboratory records.
  713. 211.194(a)(2)§ 211.194 Laboratory records.
  714. 211.194(a)(3)§ 211.194 Laboratory records.
  715. 211.194(a)(4)§ 211.194 Laboratory records.
  716. 211.194(a)(5)§ 211.194 Laboratory records.
  717. 211.194(a)(6)§ 211.194 Laboratory records.
  718. 211.194(a)(7)§ 211.194 Laboratory records.
  719. 211.194(a)(8)§ 211.194 Laboratory records.
  720. 211.194(b)§ 211.194 Laboratory records.
  721. 211.194(c)§ 211.194 Laboratory records.
  722. 211.194(d)§ 211.194 Laboratory records.
  723. 211.194(e)§ 211.194 Laboratory records.
  724. 211.196§ 211.196 Distribution records.
  725. 211.198(a)§ 211.198 Complaint files.
  726. 211.198(b)§ 211.198 Complaint files.
  727. 211.198(b)(1)§ 211.198 Complaint files.
  728. 211.198(b)(2)§ 211.198 Complaint files.
  729. 211.198(b)(3)§ 211.198 Complaint files.
  730. 211.204§ 211.204 Returned drug products.
  731. 211.208§ 211.208 Drug product salvaging.
  732. 211.22(a)§ 211.22 Responsibilities of quality control unit.
  733. 211.22(b)§ 211.22 Responsibilities of quality control unit.
  734. 211.22(c)§ 211.22 Responsibilities of quality control unit.
  735. 211.22(d)§ 211.22 Responsibilities of quality control unit.
  736. 211.25(a)§ 211.25 Personnel qualifications.
  737. 211.25(b)§ 211.25 Personnel qualifications.
  738. 211.25(c)§ 211.25 Personnel qualifications.
  739. 211.28(a)§ 211.28 Personnel responsibilities.
  740. 211.28(b)§ 211.28 Personnel responsibilities.
  741. 211.28(c)§ 211.28 Personnel responsibilities.
  742. 211.28(d)§ 211.28 Personnel responsibilities.
  743. 211.34§ 211.34 Consultants.
  744. 211.42(a)§ 211.42 Design and construction features.
  745. 211.42(b)§ 211.42 Design and construction features.
  746. 211.42(c)§ 211.42 Design and construction features.
  747. 211.42(c)(1)§ 211.42 Design and construction features.
  748. 211.42(c)(10)§ 211.42 Design and construction features.
  749. 211.42(c)(10)(i)§ 211.42 Design and construction features.
  750. 211.42(c)(10)(ii)§ 211.42 Design and construction features.
  751. 211.42(c)(10)(iii)§ 211.42 Design and construction features.
  752. 211.42(c)(10)(iv)§ 211.42 Design and construction features.
  753. 211.42(c)(10)(v)§ 211.42 Design and construction features.
  754. 211.42(c)(10)(vi)§ 211.42 Design and construction features.
  755. 211.42(c)(2)§ 211.42 Design and construction features.
  756. 211.42(c)(3)§ 211.42 Design and construction features.
  757. 211.42(c)(4)§ 211.42 Design and construction features.
  758. 211.42(c)(5)§ 211.42 Design and construction features.
  759. 211.42(c)(6)§ 211.42 Design and construction features.
  760. 211.42(c)(7)§ 211.42 Design and construction features.
  761. 211.42(c)(8)§ 211.42 Design and construction features.
  762. 211.42(c)(9)§ 211.42 Design and construction features.
  763. 211.42(d)§ 211.42 Design and construction features.
  764. 211.44§ 211.44 Lighting.
  765. 211.46(a)§ 211.46 Ventilation, air filtration, air heating and cooling.
  766. 211.46(b)§ 211.46 Ventilation, air filtration, air heating and cooling.
  767. 211.46(c)§ 211.46 Ventilation, air filtration, air heating and cooling.
  768. 211.46(d)§ 211.46 Ventilation, air filtration, air heating and cooling.
  769. 211.48(a)§ 211.48 Plumbing.
  770. 211.48(b)§ 211.48 Plumbing.
  771. 211.50§ 211.50 Sewage and refuse.
  772. 211.52§ 211.52 Washing and toilet facilities.
  773. 211.56(a)§ 211.56 Sanitation.
  774. 211.56(b)§ 211.56 Sanitation.
  775. 211.56(c)§ 211.56 Sanitation.
  776. 211.56(d)§ 211.56 Sanitation.
  777. 211.58§ 211.58 Maintenance.
  778. 211.63§ 211.63 Equipment design, size, and location.
  779. 211.65(a)§ 211.65 Equipment construction.
  780. 211.65(b)§ 211.65 Equipment construction.
  781. 211.67(a)§ 211.67 Equipment cleaning and maintenance.
  782. 211.67(b)§ 211.67 Equipment cleaning and maintenance.
  783. 211.67(b)(1)§ 211.67 Equipment cleaning and maintenance.
  784. 211.67(b)(2)§ 211.67 Equipment cleaning and maintenance.
  785. 211.67(b)(3)§ 211.67 Equipment cleaning and maintenance.
  786. 211.67(b)(4)§ 211.67 Equipment cleaning and maintenance.
  787. 211.67(b)(5)§ 211.67 Equipment cleaning and maintenance.
  788. 211.67(b)(6)§ 211.67 Equipment cleaning and maintenance.
  789. 211.67(c)§ 211.67 Equipment cleaning and maintenance.
  790. 211.68(a)§ 211.68 Automatic, mechanical, and electronic equipment.
  791. 211.68(b)§ 211.68 Automatic, mechanical, and electronic equipment.
  792. 211.80(a)§ 211.80 General requirements.
  793. 211.80(b)§ 211.80 General requirements.
  794. 211.80(c)§ 211.80 General requirements.
  795. 211.80(d)§ 211.80 General requirements.
  796. 211.82(a)§ 211.82 Receipt and storage of untested components, drug product containers, and…
  797. 211.82(b)§ 211.82 Receipt and storage of untested components, drug product containers, and…
  798. 211.84(a)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  799. 211.84(b)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  800. 211.84(c)(1)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  801. 211.84(c)(2)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  802. 211.84(c)(3)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  803. 211.84(c)(4)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  804. 211.84(c)(5)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  805. 211.84(c)(6)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  806. 211.84(d)(1)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  807. 211.84(d)(2)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  808. 211.84(d)(3)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  809. 211.84(d)(4)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  810. 211.84(d)(5)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  811. 211.84(d)(6)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  812. 211.84(e)§ 211.84 Testing and approval or rejection of components, drug product containers, and…
  813. 211.86§ 211.86 Use of approved components, drug product containers, and closures.
  814. 211.87§ 211.87 Retesting of approved components, drug product containers, and closures.
  815. 211.89§ 211.89 Rejected components, drug product containers, and closures.
  816. 211.94(a)§ 211.94 Drug product containers and closures.
  817. 211.94(b)§ 211.94 Drug product containers and closures.
  818. 211.94(c)§ 211.94 Drug product containers and closures.
  819. 211.94(d)§ 211.94 Drug product containers and closures.
  820. 212.10§ 212.10 What personnel and resources must I have?
  821. 212.100(a)§ 212.100 What do I do if I receive a complaint about a PET drug product produced at my…
  822. 212.100(b)§ 212.100 What do I do if I receive a complaint about a PET drug product produced at my…
  823. 212.100(c)§ 212.100 What do I do if I receive a complaint about a PET drug product produced at my…
  824. 212.110(b)§ 212.110 How must I maintain records of my production of PET drugs?
  825. 212.110(c)§ 212.110 How must I maintain records of my production of PET drugs?
  826. 212.20(a)§ 212.20 What activities must I perform to ensure drug quality?
  827. 212.20(b)§ 212.20 What activities must I perform to ensure drug quality?
  828. 212.20(c)§ 212.20 What activities must I perform to ensure drug quality?
  829. 212.20(d)§ 212.20 What activities must I perform to ensure drug quality?
  830. 212.20(e)§ 212.20 What activities must I perform to ensure drug quality?
  831. 212.30(a)§ 212.30 What requirements must my facilities and equipment meet?
  832. 212.30(b)§ 212.30 What requirements must my facilities and equipment meet?
  833. 212.30(c)§ 212.30 What requirements must my facilities and equipment meet?
  834. 212.40(a)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  835. 212.40(b)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  836. 212.40(c)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  837. 212.40(c)(1)(ii)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  838. 212.40(c)(2)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  839. 212.40(d)§ 212.40 How must I control the components I use to produce PET drugs and the containers…
  840. 212.50§ 212.50 What production and process controls must I have?
  841. 212.50(a)§ 212.50 What production and process controls must I have?
  842. 212.50(b)§ 212.50 What production and process controls must I have?
  843. 212.50(b)(3)§ 212.50 What production and process controls must I have?
  844. 212.50(b)(4)§ 212.50 What production and process controls must I have?
  845. 212.50(b)(5)§ 212.50 What production and process controls must I have?
  846. 212.50(b)(6)§ 212.50 What production and process controls must I have?
  847. 212.50(b)(7)§ 212.50 What production and process controls must I have?
  848. 212.50(b)(8)§ 212.50 What production and process controls must I have?
  849. 212.50(c)§ 212.50 What production and process controls must I have?
  850. 212.50(c)(10)§ 212.50 What production and process controls must I have?
  851. 212.50(c)(11)§ 212.50 What production and process controls must I have?
  852. 212.50(c)(4)§ 212.50 What production and process controls must I have?
  853. 212.50(c)(5)§ 212.50 What production and process controls must I have?
  854. 212.50(c)(7)§ 212.50 What production and process controls must I have?
  855. 212.50(c)(8)§ 212.50 What production and process controls must I have?
  856. 212.50(c)(9)§ 212.50 What production and process controls must I have?
  857. 212.50(d)§ 212.50 What production and process controls must I have?
  858. 212.50(e)§ 212.50 What production and process controls must I have?
  859. 212.50(f)(2)§ 212.50 What production and process controls must I have?
  860. 212.60(a)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  861. 212.60(b)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  862. 212.60(c)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  863. 212.60(d)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  864. 212.60(e)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  865. 212.60(f)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  866. 212.60(g)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  867. 212.60(g)(3)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  868. 212.60(g)(4)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  869. 212.60(g)(5)§ 212.60 What requirements apply to the laboratories where I test components, in-process…
  870. 212.61(a)§ 212.61 What must I do to ensure the stability of my PET drug products through expiry?
  871. 212.61(b)§ 212.61 What must I do to ensure the stability of my PET drug products through expiry?
  872. 212.70(a)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  873. 212.70(b)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  874. 212.70(c)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  875. 212.70(d)(1)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  876. 212.70(d)(2)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  877. 212.70(d)(3)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  878. 212.70(e)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  879. 212.70(f)(1)(iv)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  880. 212.70(f)(1)(vi)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  881. 212.70(f)(2)§ 212.70 What controls and acceptance criteria must I have for my finished PET drug…
  882. 212.71(a)§ 212.71 What actions must I take if a batch of PET drug product does not conform to…
  883. 212.71(b)§ 212.71 What actions must I take if a batch of PET drug product does not conform to…
  884. 212.71(c)§ 212.71 What actions must I take if a batch of PET drug product does not conform to…
  885. 212.80(d)§ 212.80 What are the requirements associated with labeling and packaging PET drug…
  886. 212.90(a)§ 212.90 What actions must I take to control the distribution of PET drug products?
  887. 225.102(a)§ 225.102 Master record file and production records.
  888. 225.102(b)(1)§ 225.102 Master record file and production records.
  889. 225.102(b)(2)§ 225.102 Master record file and production records.
  890. 225.102(b)(3)§ 225.102 Master record file and production records.
  891. 225.102(b)(4)§ 225.102 Master record file and production records.
  892. 225.102(b)(5)§ 225.102 Master record file and production records.
  893. 225.10(b)(1)§ 225.10 Personnel.
  894. 225.10(b)(2)§ 225.10 Personnel.
  895. 225.110(b)§ 225.110 Distribution records.
  896. 225.110(b)(1)§ 225.110 Distribution records.
  897. 225.115(b)(1)§ 225.115 Complaint files.
  898. 225.115(b)(2)§ 225.115 Complaint files.
  899. 225.120§ 225.120 Buildings and grounds.
  900. 225.130§ 225.130 Equipment.
  901. 225.135§ 225.135 Work and storage areas.
  902. 225.142§ 225.142 Components.
  903. 225.158§ 225.158 Laboratory assays.
  904. 225.165§ 225.165 Equipment cleanout procedures.
  905. 225.180§ 225.180 Labeling.
  906. 225.202§ 225.202 Formula, production, and distribution records.
  907. 225.20(a)§ 225.20 Buildings.
  908. 225.20(b)(1)§ 225.20 Buildings.
  909. 225.20(b)(2)§ 225.20 Buildings.
  910. 225.20(b)(3)§ 225.20 Buildings.
  911. 225.20(b)(4)§ 225.20 Buildings.
  912. 225.30(a)§ 225.30 Equipment.
  913. 225.30(b)(1)§ 225.30 Equipment.
  914. 225.30(b)(2)§ 225.30 Equipment.
  915. 225.30(b)(3)§ 225.30 Equipment.
  916. 225.30(b)(4)§ 225.30 Equipment.
  917. 225.30(b)(5)§ 225.30 Equipment.
  918. 225.30(b)(6)§ 225.30 Equipment.
  919. 225.35(b)§ 225.35 Use of work areas, equipment, and storage areas for other manufacturing and…
  920. 225.42(b)§ 225.42 Components.
  921. 225.42(b)(1)§ 225.42 Components.
  922. 225.42(b)(2)§ 225.42 Components.
  923. 225.42(b)(3)§ 225.42 Components.
  924. 225.42(b)(4)§ 225.42 Components.
  925. 225.42(b)(5)§ 225.42 Components.
  926. 225.42(b)(6)§ 225.42 Components.
  927. 225.42(b)(7)§ 225.42 Components.
  928. 225.42(b)(8)§ 225.42 Components.
  929. 225.58(b)(1)§ 225.58 Laboratory controls.
  930. 225.58(c)§ 225.58 Laboratory controls.
  931. 225.58(d)§ 225.58 Laboratory controls.
  932. 225.58(e)§ 225.58 Laboratory controls.
  933. 225.65(b)§ 225.65 Equipment cleanout procedures.
  934. 225.65(b)(2)§ 225.65 Equipment cleanout procedures.
  935. 225.65(b)(3)§ 225.65 Equipment cleanout procedures.
  936. 225.80(a)§ 225.80 Labeling.
  937. 225.80(b)(1)§ 225.80 Labeling.
  938. 225.80(b)(2)§ 225.80 Labeling.
  939. 225.80(b)(3)§ 225.80 Labeling.
  940. 225.80(b)(4)§ 225.80 Labeling.
  941. 226.1§ 226.1 Current good manufacturing practice.
  942. 226.102(a)(1)§ 226.102 Master-formula and batch-production records.
  943. 226.102(a)(4)§ 226.102 Master-formula and batch-production records.
  944. 226.102(b)(2)§ 226.102 Master-formula and batch-production records.
  945. 226.110§ 226.110 Distribution records.
  946. 226.115§ 226.115 Complaint files.
  947. 226.20§ 226.20 Buildings.
  948. 226.20(a)(4)§ 226.20 Buildings.
  949. 226.20(b)§ 226.20 Buildings.
  950. 226.30§ 226.30 Equipment.
  951. 226.30(c)§ 226.30 Equipment.
  952. 226.30(e)§ 226.30 Equipment.
  953. 226.40(b)§ 226.40 Production and control procedures.
  954. 226.40(c)§ 226.40 Production and control procedures.
  955. 226.40(d)§ 226.40 Production and control procedures.
  956. 226.40(e)§ 226.40 Production and control procedures.
  957. 226.40(f)§ 226.40 Production and control procedures.
  958. 226.40(g)§ 226.40 Production and control procedures.
  959. 226.42(a)§ 226.42 Components.
  960. 226.58(a)§ 226.58 Laboratory controls.
  961. 226.58(b)§ 226.58 Laboratory controls.
  962. 226.58(c)(1)§ 226.58 Laboratory controls.
  963. 226.58(d)§ 226.58 Laboratory controls.
  964. 226.58(e)§ 226.58 Laboratory controls.
  965. 226.80(a)(2)§ 226.80 Packaging and labeling.
  966. 226.80(a)(3)§ 226.80 Packaging and labeling.
  967. 226.80(a)(4)§ 226.80 Packaging and labeling.
  968. 226.80(b)(2)§ 226.80 Packaging and labeling.
  969. 226.80(b)(3)§ 226.80 Packaging and labeling.
  970. 310.305(a)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  971. 310.305(c)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  972. 310.305(c)(1)(i)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  973. 310.305(c)(2)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  974. 310.305(d)(1)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  975. 310.305(g)(3)§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription…
  976. 312.120(c)§ 312.120 Foreign clinical studies not conducted under an IND.
  977. 312.20(a)§ 312.20 Requirement for an IND.
  978. 312.20(b)§ 312.20 Requirement for an IND.
  979. 312.20(c)§ 312.20 Requirement for an IND.
  980. 312.50§ 312.50 General responsibilities of sponsors.
  981. 312.52(a)§ 312.52 Transfer of obligations to a contract research organization.
  982. 312.53(a)§ 312.53 Selecting investigators and monitors.
  983. 312.53(b)§ 312.53 Selecting investigators and monitors.
  984. 312.53(c)(1)§ 312.53 Selecting investigators and monitors.
  985. 312.53(c)(2)§ 312.53 Selecting investigators and monitors.
  986. 312.53(c)(4)§ 312.53 Selecting investigators and monitors.
  987. 312.53(d)§ 312.53 Selecting investigators and monitors.
  988. 312.55(a)§ 312.55 Informing investigators.
  989. 312.55(b)§ 312.55 Informing investigators.
  990. 312.56(a)§ 312.56 Review of ongoing investigations.
  991. 312.56(b)§ 312.56 Review of ongoing investigations.
  992. 312.56(c)§ 312.56 Review of ongoing investigations.
  993. 312.57(a)§ 312.57 Recordkeeping and record retention.
  994. 312.57(b)§ 312.57 Recordkeeping and record retention.
  995. 312.57(c)§ 312.57 Recordkeeping and record retention.
  996. 312.57(d)§ 312.57 Recordkeeping and record retention.
  997. 312.58(a)§ 312.58 Inspection of sponsor's records and reports.
  998. 312.59§ 312.59 Disposition of unused supply of investigational drug.
  999. 312.60§ 312.60 General responsibilities of investigators.
  1000. 312.61§ 312.61 Control of the investigational drug.

About this dataset

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data