CFR section
21 CFR 111.535(b): Under this subpart N, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart N-Returned Dietary Supplements
Key facts
| Citation | 21 CFR 111.535(b) |
|---|---|
| Section | Under this subpart N, what records must you make and keep? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart N-Returned Dietary Supplements |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (b) You must make and keep the following records: (1) Written procedures for fulfilling the requirements of this subpart N. (2) Any material review and disposition decision on a returned dietary supplement; (3) The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and, (4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality… |
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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.