21 CFR 111.210
What must the master manufacturing record include?
21 CFR 111.210 is the regulation titled “What must the master manufacturing record include?” in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Since 2021, 9 FDA warning letters have cited it.
- Letters citing it
- 9 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 111.70, in 9 letters
- Closed out
- 11% 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 111.210 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 establish master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, the MMRs for your Lycium Formula Huan Shao Dan, **(b)(4)**, and **(b)(4)** Zinc…
- 1 letterYou failed to establish master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, your master manufacturing records for **(b)(4)** (120 Capsules) and **(b)(4)** (60…
The regulation
Read the text of 21 CFR 111.210 (eCFR, as of Sep 1, 2026)
The master manufacturing record must include:
(a) The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size;
(b) A complete list of components to be used;
(c) An accurate statement of the weight or measure of each component to be used;
(d) The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement;
(e) A statement of any intentional overage amount of a dietary ingredient;
(f) A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made;
(g) A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label;
(h) Written instructions, including the following:
(1) Specifications for each point, step, or stage 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;
(2) Procedures for sampling and a cross-reference to procedures for tests or examinations;
(3) Specific actions necessary to perform and verify 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.
(i) Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component; and
(ii) For manual operations, such specific actions must include:
(A) One person weighing or measuring a component and another person verifying the weight or measure; and
(B) One person adding the component and another person verifying the addition.
(4) Special notations and precautions to be followed; and
(5) Corrective action plans for use when a specification is not met.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 111.210.
- 21 CFR 111.70What specifications must you establish?9 letters cite both
- 21 CFR 111.260What must the batch record include?8 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?7 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use7 letters cite both
- 21 CFR 101.36Nutrition labeling of dietary supplements6 letters cite both
- 21 CFR 101.4Food; designation of ingredients6 letters cite both
- 21 CFR 111.255What is the requirement to establish a batch production record?6 letters cite both
- 21 CFR 101.9Nutrition labeling of food5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 111.210 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 Natural Relief Inc.Edema NatRelief 6 and BP NatRelief 11IssuedOct 18, 2023PostedNov 14, 2023
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