CFR section
21 CFR 111.180(b)(3): Under this subpart G, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart G-Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
Key facts
| Citation | 21 CFR 111.180(b)(3) |
|---|---|
| Section | Under this subpart G, 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 G-Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics, Other_Regulations |
| Regulation text (excerpt) | (3) Documentation that the requirements of this subpart were met. (i) The person who performs the required operation must document, at the time of performance, that the required operation was performed. (ii) The documentation must include: (A) The date that the components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement were received; (B) The initials of the person performing the required operation; (C) The results of any tests or examinations… |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.