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21 CFR 211.170(b) citations

Reserve samples identified, representative, stored

FDA investigators cited 21 CFR 211.170(b) 393 times at 326 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 13, 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
202611
202521
202415
202313
202213
202115
20207
201929
201833
201725

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 13, 2026Conopco Inc. D/B/A UnileverUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
May 13, 2026Advagen Holdings, Inc.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Apr 14, 2026KDC/ONE SOCAL LABORATORIES, LLCUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Apr 2, 2026Deciem Inc.CanadaReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Mar 2, 2026Coupler LLCUnited StatesReserve drug product samples are not representative of each lot or batch of drug product.
Feb 27, 2026Gasco Industrial Corp.United StatesReserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Feb 18, 2026Gilead Sciences, Inc.United StatesReserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Feb 18, 2026Gilead Sciences, Inc.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Dec 9, 2025Bavarian Nordic A/SDenmarkReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Dec 4, 2025St Mary's Medical Park PharmacyUnited StatesReserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
Oct 9, 2025Precare CorpUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Sep 26, 2025Cosmetic Enterprises LtdUnited StatesReserve drug product samples are not representative of each lot or batch of drug product.
Sep 15, 2025Pharbest Pharmaceuticals, Inc.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Aug 22, 2025Chemco CorporationUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Jul 28, 2025DOH Central PharmacyUnited StatesReserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Jul 16, 2025BSO LLCUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Jun 26, 2025Atlantis Laboratories, Inc.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Jun 16, 2025HPC VenturesUnited StatesReserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
May 16, 2025K.W. Griffen CompanyUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
May 13, 2025Elba, Inc.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
May 5, 2025Geri-Care Pharmaceuticals Corp.United StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Mar 28, 2025APIPHARMA D.O.OCroatiaReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Mar 21, 2025Lavet Kft.HungaryReserve drug product samples are not retained and stored under conditions consistent with product labeling.
Feb 21, 2025Tai Guk Pharm Co., Ltd.Korea (the Republic of)Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Feb 12, 2025Aidance Scientific IncUnited StatesReserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

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