21 CFR 111.127
What quality control operations are required for packaging and labeling operations?
21 CFR 111.127 is the regulation titled “What quality control operations are required for packaging and labeling operations?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.36, in 2 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.
- 02021
- 22022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 111.127 (eCFR, as of Sep 1, 2026)
Quality control operations for packaging and labeling operations must include:
(a) Reviewing the results of any visual examination and documentation to ensure that specifications established under § 111.70(f) are met for all products that you receive for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier);
(b) Approving, and releasing from quarantine, all products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) before they are used for packaging or labeling;
(c) Reviewing and approving all records for packaging and label operations;
(d) Determining whether the finished packaged and labeled dietary supplement conforms to specifications established in accordance with § 111.70(g);
(e) Conducting any required material review and making any required disposition decision;
(f) Approving or rejecting any repackaging of a packaged dietary supplement;
(g) Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and
(h) Approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.127.
- 21 CFR 101.36Nutrition labeling of dietary supplements2 letters cite both
- 21 CFR 101.4Food; designation of ingredients2 letters cite both
- 21 CFR 101.9Nutrition labeling of food2 letters cite both
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?2 letters cite both
- 21 CFR 111.105What must quality control personnel do?2 letters cite both
- 21 CFR 111.55What are the requirements to implement a production and process control system?2 letters cite both
- 21 CFR 111.70What specifications must you establish?2 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use2 letters cite both
Latest letters citing it
The 2 letters citing 21 CFR 111.127 that FDA posted most recently.
- DrugsView Deggeh Foods, Inc.Actibest Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, Moringa Tea BagsIssuedJul 29, 2022PostedAug 16, 2022
- DrugsView C R Supplements, LLCCalcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost PackIssuedApr 20, 2022PostedMay 3, 2022
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