---
kind: "section"
citation: "21 C.F.R. § 111.113"
title: "21"
number: "111.113"
heading: "What quality control operations are required for a material review and disposition decision?"
url: "https://uscodex.org/cfr/21/111.113"
---

# §111.113. What quality control operations are required for a material review and disposition decision?

- (a) Quality control personnel must conduct a material review and make a disposition decision if:
  - (1) A specification established in accordance with [§ 111.70](/cfr/21/111.70.md) is not met;
  - (2) A batch deviates from the master manufacturing record, including when any step established in the master manufacturing record is not completed and including any deviation from specifications;
  - (3) There is any unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record;
  - (4) Calibration of an instrument or control suggests a problem that may have resulted in a failure to ensure the quality of a batch or batches of a dietary supplement; or
  - (5) **A dietary supplement is returned.**
- (b)
  - (1) When there is a deviation or unanticipated occurrence during the production and in-process control system that results in or could lead to adulteration of a component, dietary supplement, or packaging, or could lead to the use of a label not specified in the master manufacturing record, quality control personnel must reject the component, dietary supplement, packaging, or label unless it approves a treatment, an in-process adjustment, or reprocessing to correct the applicable deviation or occurrence.
  - (2) When a specification established in accordance with [§ 111.70](/cfr/21/111.70.md) is not met, quality control personnel must reject the component, dietary supplement, package or label, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in [§ 111.77](/cfr/21/111.77.md).
- (c) The person who conducts a material review and makes the disposition decision must, at the time of performance, document that material review and disposition decision.

## 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.