21 CFR 211.100
Written procedures; deviations
21 CFR 211.100 is the regulation titled “Written procedures; deviations” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 243 FDA warning letters have cited it.
- Letters citing it
- 243 since 2021
- Jan 1 to Oct 30, 2026
- 43 against 44 on the same dates in 2025
- Most often cited with
- 21 CFR 211.84, in 150 letters
- Closed out
- 5% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (217 of 243). 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 211.100 most often, as written in the letters.
- 89 lettersYour firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are…
- 33 lettersYour firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are…
- 11 lettersYour firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are…
The regulation
Read the text of 21 CFR 211.100 (eCFR, as of Sep 1, 2026)
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.100.
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures150 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit147 letters cite both
- 21 CFR 211.166Stability testing105 letters cite both
- 21 CFR 211.165Testing and release for distribution104 letters cite both
- 21 CFR 211.192Production record review84 letters cite both
- 21 CFR 211.160General requirements71 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance58 letters cite both
- 21 CFR 211.188Batch production and control records53 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.100 that FDA posted most recently.
- DrugsView Pritam International Private LimitedBrush Buddies Cookies 'n Cream Ice Cream Flavored ToothpasteIssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Guangdong Bangze Medicine Co., Ltd.OTC drug productsIssuedOct 26, 2026PostedNov 3, 2026
- DrugsView Sanrace Biotechnology Co., Ltd.Over-the-counter (OTC) drug productsIssuedOct 22, 2026PostedOct 27, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.