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21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals

§ 211.192 Production record review

Subpart J - Records and Reports Official text on eCFR Amendment history

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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 211.192

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

  • Investigations of discrepancies, failures 1,536
  • Written record of investigation incomplete 384
  • Quality control unit review of records 330
  • No written record of investigation 285
  • Extent of discrepancy, failure investigations 254

Warning letters citing § 211.192

315 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 211.192

and 8 more.

Amendment history

Federal Register documents that created or amended this section.