CFR section
21 CFR 111.570(b): Under this subpart O, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart O-Product Complaints
Key facts
| Citation | 21 CFR 111.570(b) |
|---|---|
| Section | Under this subpart O, 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 O-Product Complaints |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (b) You must make and keep the following records: (1) Written procedures for fulfilling the requirements of this subpart, (2) A written record of every product complaint that is related to good manufacturing practice, (i) The person who performs the requirements of this subpart must document, at the time of performance, that the requirement was performed. (ii) The written record of the product complaint must include the following: (A) The name and description of the dietary supplement; (B) The… |
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.