21 CFR 111.113
What quality control operations are required for a material review and disposition decision?
21 CFR 111.113 is the regulation titled “What quality control operations are required for a material review and disposition decision?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 111.70, in 4 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 111.113 (eCFR, as of Sep 1, 2026)
(a) Quality control personnel must conduct a material review and make a disposition decision if:
(1) A specification established in accordance with § 111.70 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 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.
(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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.113.
- 21 CFR 111.70What specifications must you establish?4 letters cite both
- 21 CFR 111.210What must the master manufacturing record include?3 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?3 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use3 letters cite both
- 21 CFR 111.260What must the batch record include?2 letters cite both
- 21 CFR 111.315What are the requirements for laboratory control processes?2 letters cite both
- 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?2 letters cite both
- 21 CFR 111.73What is your responsibility for determining whether established specifications are met?2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.113 that FDA posted most recently.
- DrugsView Imu-Tek Animal Health, IncorporatedColostrum-5 Capsules and Colostrum-5 PowderIssuedJun 5, 2026PostedJun 23, 2026
- DrugsView STPCA Inc. dba Sun Ten Laboratoriesdietary supplements and unapproved drugsIssuedApr 7, 2023PostedAug 15, 2023
- DrugsView EarthLab, Inc., dba Wise Woman HerbalsGreen Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Healthy Prostate, Turmeric Gold Capsules, Upper Respiratory Support,…IssuedApr 27, 2023PostedMay 16, 2023
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