21 CFR 211.192
Production record review
21 CFR 211.192 is the regulation titled “Production record review” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 193 FDA warning letters have cited it.
- Letters citing it
- 193 since 2021
- Jan 1 to Oct 30, 2026
- 41 against 36 on the same dates in 2025
- Most often cited with
- 21 CFR 211.100, in 84 letters
- Closed out
- 10% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (176 of 193). 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 211.192 most often, as written in the letters.
- 134 lettersYour firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR…
- 3 lettersYour firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv))
- 3 lettersYour firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic…
The regulation
Read the text of 21 CFR 211.192 (eCFR, as of Sep 1, 2026)
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.192.
- 21 CFR 211.100Written procedures; deviations84 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit84 letters cite both
- 21 CFR 211.113Control of microbiological contamination67 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures61 letters cite both
- 21 CFR 211.160General requirements58 letters cite both
- 21 CFR 211.42Design and construction features58 letters cite both
- 21 CFR 211.165Testing and release for distribution51 letters cite both
- 21 CFR 211.166Stability testing47 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.192 that FDA posted most recently.
- DrugsView Rohto Pharmaceutical Co., Ltd.Over-the-counter topical ophthalmic drug products manufactured using aseptic processing.IssuedOct 14, 2026PostedOct 20, 2026
- DrugsView Baxter International Inc.Sterile injectable drugs, including cephalosporins and other productsIssuedSep 29, 2026PostedOct 20, 2026
- DrugsView SnugZ USA, Inc.OTC drug products distributed as promotional itemsIssuedSep 28, 2026PostedOct 20, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.