21 CFR 211.186
Master production and control records
21 CFR 211.186 is the regulation titled “Master production and control records” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 4 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 211.186 most often, as written in the letters.
- 1 letterYour firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch. Your firm also failed to prepare batch…
The regulation
Read the text of 21 CFR 211.186 (eCFR, as of Sep 1, 2026)
(a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.
(b) Master production and control records shall include:
(1) The name and strength of the product and a description of the dosage form;
(2) The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product, and a statement of the total weight or measure of any dosage unit;
(3) A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic;
(4) An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component. Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records;
(5) A statement concerning any calculated excess of component;
(6) A statement of theoretical weight or measure at appropriate phases of processing;
(7) A statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation according to § 211.192 is required;
(8) A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling;
(9) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.186.
- 21 CFR 211.22Responsibilities of quality control unit4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3 letters cite both
- 21 CFR 201.128Meaning of “intended uses”2 letters cite both
- 21 CFR 211.165Testing and release for distribution2 letters cite both
- 21 CFR 211.188Batch production and control records2 letters cite both
- 21 CFR 211.25Personnel qualifications2 letters cite both
- 21 CFR 207.17Who must register?1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 211.186 that FDA posted most recently.
- DrugsView PMS4PMS, LLCComforté® Menstrual Cramp RELIEF CREAMIssuedApr 7, 2025PostedApr 15, 2025
- DrugsView LCC Ltd.Contract manufacturer of OTC mouthwash drug productsIssuedNov 21, 2024PostedDec 3, 2024
- DrugsView Les Importations Herbasanté Inc.homeopathic drug productsIssuedJan 31, 2024PostedFeb 6, 2024
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