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21 CFR 211.192 citations

Written record of investigation incomplete

FDA investigators cited 21 CFR 211.192 2,801 times at 1,798 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 23, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
2026134
2025211
2024140
2023127
2022126
202177
202090
2019183
2018156
2017154

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Sep 23, 2026Baxter Healthcare CorporationUnited StatesThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Sep 4, 2026ACTA Laboratories, Inc.United StatesWritten records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Sep 3, 2026Microbac Laboratories, Inc.United StatesWritten records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Aug 12, 2026Steril-Gene Life Sciences Private LtdIndiaThere 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.
Jul 31, 2026Episciences IncUnited StatesWritten records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
Jul 28, 2026Graviti Pharmaceuticals Private LimitedIndiaThere 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.
Jul 23, 2026Fuller Industries IncUnited StatesWritten records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Jul 20, 2026Biochemical And Scientific Consultants CcSouth AfricaThere 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.
Jul 17, 2026I. Shay Cosmetics IncUnited StatesThere 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.
Jul 16, 2026Bryant Ranch PrePackUnited StatesThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jul 14, 2026Aspen SA Sterile Operations (Pty) Ltd.South AfricaThere 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.
Jul 10, 2026Playtex Manufacturing IncUnited StatesWritten records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Jul 9, 2026Lexamed, LtdUnited StatesThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jun 30, 2026Carlsbad Technology, IncUnited StatesThere 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.
Jun 30, 2026Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P.United StatesThere 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.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesThere 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.
Jun 26, 2026Natural Essentials IncorporatedUnited StatesThere 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.
Jun 26, 2026S.S.S. Company (International)United StatesThere 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.
Jun 23, 2026Scinopharm Taiwan, Ltd.TaiwanThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jun 16, 2026Advanced Testing Laboratory IncUnited StatesThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jun 12, 2026Product Society LLCUnited StatesThere 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.
Jun 12, 2026Safecor Health, LLCUnited StatesThere 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.
Jun 10, 2026ARx LLCUnited StatesThere 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.
Jun 10, 2026ARx LLCUnited StatesDrug product production and control records, are not by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Jun 9, 2026The Procter & Gamble Manufacturing CompanyUnited StatesThere is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.