21 CFR 111.255
What is the requirement to establish a batch production record?
21 CFR 111.255 is the regulation titled “What is the requirement to establish a batch production record?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 12 FDA warning letters have cited it.
- Letters citing it
- 12 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 111.260, in 12 letters
- Closed out
- 17% 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 111.255 most often, as written in the letters.
- 1 letterYou failed to establish a batch production record (BPR) that satisfies the requirements of 21 CFR 111.255 and 111.260. For example, the BPRs for the BP Nat Relief, 11 Lot **(b)(4)**, and Edema NatRelief 6, Lot…
- 1 letterYou failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or…
- 1 letterYou failed to prepare a batch production record every time you manufactured a batch of dietary supplement as required by 21 CFR 111.255(a). Specifically, during the inspection, your firm did not have batch production…
The regulation
Read the text of 21 CFR 111.255 (eCFR, as of Sep 1, 2026)
(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;
(b) Your batch production record must include complete information relating to the production and control of each batch;
(c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and
(d) You must make and keep batch production records in accordance with subpart P of this part.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.255.
- 21 CFR 111.260What must the batch record include?12 letters cite both
- 21 CFR 111.70What specifications must you establish?11 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use11 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?10 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements8 letters cite both
- 21 CFR 101.4Food; designation of ingredients8 letters cite both
- 21 CFR 101.9Nutrition labeling of food8 letters cite both
- 21 CFR 101.12Reference amounts customarily consumed per eating occasion6 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.255 that FDA posted most recently.
- DrugsView Mineral BioSciences, LLCTotala Fulvic Ionic Mineral Complex and IonicellIssuedJun 5, 2026PostedJul 21, 2026
- DrugsView Meta Labs Pharmaceuticals, LLCDietary supplements and unapproved drugs sold onlineIssuedMay 15, 2026PostedJun 2, 2026
- DrugsView Mericon Industries, Inc.Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 CapsulesIssuedJul 17, 2025PostedSep 16, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.