21 CFR 111.205
What is the requirement to establish a master manufacturing record?
21 CFR 111.205 is the regulation titled “What is the requirement to establish a master manufacturing record?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 7 FDA warning letters have cited it.
- Letters citing it
- 7 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 111.260, in 7 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 111.205 most often, as written in the letters.
- 1 letterYou failed to establish master manufacturing records (MMRs) that identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary…
- 1 letterYou failed to prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured, to ensure…
- 1 letterYou failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch…
The regulation
Read the text of 21 CFR 111.205 (eCFR, as of Sep 1, 2026)
(a) You must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.
(b) The master manufacturing record must:
(1) Identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
(2) Establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified in accordance with paragraph (b)(1) of this section.
(c) You must make and keep master manufacturing 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 111.205.
- 21 CFR 111.260What must the batch record include?7 letters cite both
- 21 CFR 111.70What specifications must you establish?7 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use7 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?6 letters cite both
- 21 CFR 111.210What must the master manufacturing record include?5 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?5 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements4 letters cite both
- 21 CFR 101.4Food; designation of ingredients4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.205 that FDA posted most recently.
- DrugsView Imu-Tek Animal Health, IncorporatedColostrum-5 Capsules and Colostrum-5 PowderIssuedJun 5, 2026PostedJun 23, 2026
- DrugsView Meta Labs Pharmaceuticals, LLCDietary supplements and unapproved drugs sold onlineIssuedMay 15, 2026PostedJun 2, 2026
- DrugsView Mother Earth Minerals, Inc.Dietary supplements and mineral products (Calcium, Magnesium, Silver)IssuedMar 28, 2025PostedJun 3, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.