21 CFR 111.105
What must quality control personnel do?
21 CFR 111.105 is the regulation titled “What must quality control personnel do?” 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 201.5, 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 111.105 (eCFR, as of Sep 1, 2026)
Quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. To do so, quality control personnel must perform operations that include:
(a) Approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement;
(b) Reviewing and approving the documentation setting forth the basis for qualification of any supplier;
(c) Reviewing and approving the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met;
(d) Reviewing and approving the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification selected under § 111.75(c)(1) will ensure that the finished batch of the dietary supplement meets product specifications;
(e) Reviewing and approving the basis and the documentation for why any product specification is exempted from the verification requirements in § 111.75(c)(1), and for why any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specification is met without verification through periodic testing of the finished batch;
(f) Ensuring that required representative samples are collected;
(g) Ensuring that required reserve samples are collected and held;
(h) Determining whether all specifications established under § 111.70(a) are met; and
(i) Performing other operations required under this subpart.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.105.
- 21 CFR 201.5Drugs; adequate directions for use4 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements3 letters cite both
- 21 CFR 101.4Food; designation of ingredients3 letters cite both
- 21 CFR 101.9Nutrition labeling of food3 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?3 letters cite both
- 21 CFR 111.260What must the batch record include?3 letters cite both
- 21 CFR 111.70What specifications must you establish?3 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.105 that FDA posted most recently.
- DrugsView Mineral BioSciences, LLCTotala Fulvic Ionic Mineral Complex and IonicellIssuedJun 5, 2026PostedJul 21, 2026
- DrugsView Spartan Enterprises Inc. dba Watershed Wellness Centerdietary supplementsIssuedMar 8, 2023PostedApr 25, 2023
- DrugsView Deggeh Foods, Inc.Actibest Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, Moringa Tea BagsIssuedJul 29, 2022PostedAug 16, 2022
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