CFR section
21 CFR 111.15(c)(2): What sanitation requirements apply to your physical plant and grounds?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart C-Physical Plant and Grounds
Key facts
| Citation | 21 CFR 111.15(c)(2) |
|---|---|
| Section | What sanitation requirements apply to your physical plant and grounds? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart C-Physical Plant and Grounds |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (2) You must not use or hold toxic materials in a physical plant in which components, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary as follows: (i) To maintain clean and sanitary conditions; (ii) For use in laboratory testing procedures; (iii) For maintaining or operating the physical plant or equipment; or (iv) For use in the plant's operations. |
At a glance
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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.