---
kind: "section"
citation: "21 C.F.R. § 111.180"
title: "21"
number: "111.180"
heading: "Under this subpart G, what records must you make and keep?"
url: "https://uscodex.org/cfr/21/111.180"
---

# §111.180. Under this subpart G, what records must you make and keep?

- (a) You must make and keep records required under this subpart G in accordance with subpart P of this part.
- (b) You must make and keep the following records:
  - (1) **Written procedures for fulfilling the requirements of this subpart.**
  - (2) Receiving records (including records such as certificates of analysis, suppliers' invoices, and suppliers' guarantees) for components, packaging, and labels and for products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and
  - (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 conducted on components, packaging, or labels, and of any visual examination of product that you receive for packaging or labeling as a dietary supplement; and
      - (D) Any material review and disposition decision conducted on components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.