---
kind: "section"
citation: "21 C.F.R. § 111.570"
title: "21"
number: "111.570"
heading: "Under this subpart O, what records must you make and keep?"
url: "https://uscodex.org/cfr/21/111.570"
---

# §111.570. Under this subpart O, what records must you make and keep?

- (a) You must make and keep the records required under this subpart O 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) 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 batch, lot, or control number of the dietary supplement, if available;
      - (C) The date the complaint was received and the name, address, or telephone number of the complainant, if available;
      - (D) The nature of the complaint including, if known, how the product was used;
      - (E) The reply to the complainant, if any; and
      - (F) **Findings of the investigation and followup action taken when an investigation is performed.**

## 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.