21 CFR 111.123
What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
21 CFR 111.123 is the regulation titled “What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing 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 101.12, in 2 letters
- Closed out
- 50% 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
- 02022
- 22023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 111.123 most often, as written in the letters.
- 1 letterYou failed to prepare a written master manufacturing record (MMR) that includes written instructions for corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5).…
The regulation
Read the text of 21 CFR 111.123 (eCFR, as of Sep 1, 2026)
(a) Quality control operations for the master manufacturing record, the batch production record, and manufacturing operations must include:
(1) Reviewing and approving all master manufacturing records and all modifications to the master manufacturing records;
(2) Reviewing and approving all batch production-related records;
(3) Reviewing all monitoring required under subpart E;
(4) Conducting any required material review and making any required disposition decision;
(5) Approving or rejecting any reprocessing;
(6) Determining whether all in-process specifications established in accordance with § 111.70(c) are met;
(7) Determining whether each finished batch conforms to product specifications established in accordance with § 111.70(e); and
(8) Approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch.
(b) Quality control personnel must not approve and release for distribution:
(1) Any batch of dietary supplement for which any component in the batch does not meet its identity specification;
(2) Any batch of dietary supplement, including any reprocessed batch, that does not meet all product specifications established in accordance with § 111.70(e);
(3) Any batch of dietary supplement, including any reprocessed batch, that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act; and
(4) Any product received from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for which sufficient assurance is not provided to adequately identify the product and to determine that the product is consistent with your purchase order.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.123.
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion2 letters cite both
- 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 111.210What must the master manufacturing record include?2 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?2 letters cite both
- 21 CFR 111.260What must the batch record include?2 letters cite both
- 21 CFR 111.70What specifications must you establish?2 letters cite both
Latest letters citing it
The 2 letters citing 21 CFR 111.123 that FDA posted most recently.
- DrugsView Spartan Enterprises Inc. dba Watershed Wellness Centerdietary supplementsIssuedMar 8, 2023PostedApr 25, 2023
- DrugsView Herbal Vitality, Inc.Unapproved drugs and dietary supplementsIssuedMar 7, 2023PostedMar 21, 2023
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