CFR section
21 CFR 211.184(d): Component, drug product container, closure, and labeling records
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 211.184(d) |
|---|---|
| Section | Component, drug product container, closure, and labeling records |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (d) Documentation of the examination and review of labels and labeling for conformity with established specifications in accord with §§ 211.122(c) and 211.130(c). |
At a glance
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- 1–9 Warning letters citing this section
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About CFR sections cited by the FDA
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.