§ 211.192 Production record review.
Cited in 3 FDA warning lettersHow BatchGlow handles this
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.
Cited in FDA warning letters
3 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.
- Active Cosmetics Manufacturing Inc. · 22 Apr 2026
violation 1: 21 CFR 211.192 - Columbia Cosmetics Manufacturing Inc. · 11 Sep 2025
violation 1: 21 CFR 211.192 - Accra-Pac, Inc. dba Voyant Beauty · 20 Apr 2023
violation 1: 21 CFR 211.192
How BatchGlow handles this
A result out of specification opens an OOS investigation, and a failed yield, variance or check opens a deviation. For a drug material, the investigation is concluded by a second QC user, not by the analyst who entered the result.
What it asks for, in plain words
- 21 CFR 211.192
- The quality control unit reviews and approves all production and control records, packaging and labeling included, before a batch is released or distributed. Any unexplained discrepancy or failure to meet specifications is thoroughly investigated, extended to other batches that may be affected, and recorded in writing with conclusions and follow-up.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.