21 CFR 211.192: Production record review
Requires the quality control unit to review and approve all production, control, packaging, and labeling records before batch release, and to thoroughly investigate and document any unexplained discrepancy or specification failure, including impact on other batches.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart J, Records and Reports
42%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.192, from the 483s we hold.
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.Most used
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Cited over time
483s citing 211.192, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.192
- Right Value Drug Stores LLC · Irving, TexasThere is a failure to thoroughly review any unexplained discrepancy whether or not… Sep 8, 2026
- RC Outsourcing, LLC · Lowellville, OhioThere is a failure to thoroughly review any unexplained discrepancy and the failure… Sep 3, 2026
- Houston Rx LLC · Houston, TexasMicrobial contamination was present in the ISO 5 area… Aug 28, 2026
- Tai ls t o rm Hea l th · Chandler, ArizonaWritten records are not always made of investigations into unexplained… Aug 28, 2026
- Imprimis NJOF, LLC · Ledgewoo d, New JerseyThere is a failure to thoroughly review any unexplained discrepancy and the failure… Aug 18, 2026
The regulation text
§ 211.192 Production record review.
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.
Questions
What does 21 CFR 211.192 require?
Requires the quality control unit to review and approve all production, control, packaging, and labeling records before batch release, and to thoroughly investigate and document any unexplained discrepancy or specification failure, including impact on other batches.
How often is 211.192 cited in Form 483s?
It appears in about 42% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the five most-cited sections in those 483s.
How do FDA investigators word a 211.192 observation?
The most common opening is: “There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.”
Which sections are cited alongside 211.192?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.113 (Control of microbiological contamination), 211.67 (Equipment cleaning and maintenance).