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21 CFR 211.165(e) citations

Test methods

FDA investigators cited 21 CFR 211.165(e) 401 times at 364 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jun 19, 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
20268
202521
202418
202322
202217
20218
202011
201936
201823
201742

Recent citations

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

Inspection endedFacilityCountryObservation
Jun 19, 2026Nowcos Co., Ltd.Korea (the Republic of)The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Jun 12, 2026Product Society LLCUnited StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Mar 27, 2026Allure Labs, LLCUnited StatesThe accuracy of test methods have not been established.
Mar 23, 2026Dr. J Skinclinic, IncUnited StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Feb 13, 2026K.C. Pharmaceuticals, Inc.United StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Jan 30, 2026Hibrow Healthcare Private LimitedIndiaThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Dec 17, 2025APL HEALTHCARE LIMITEDIndiaThe accuracy of test methods have not been established and documented.
Nov 21, 2025Sato Pharmaceutical Co., Ltd.JapanThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Sep 5, 2025Central Admixture Pharmacy Services, Inc.United StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Sep 5, 2025Central Admixture Pharmacy Services, Inc.United StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Sep 4, 2025Sparsha Pharma Usa IncUnited StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Jun 4, 2025DeVere Company, Inc.United StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
May 23, 2025Borden Company (Private) LimitedSingaporeThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Apr 25, 2025Innocore Sales & Marketing Inc.CanadaThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Apr 25, 2025RadnostixUnited StatesThe accuracy and reproducibility of test methods have not been established and documented.
Apr 24, 2025Absolutely NaturalUnited StatesThe accuracy, sensitivity and specificity of test methods have not been established.
Apr 18, 2025C. B. Fleet Company, Inc.United StatesThe specificity of test methods have not been established.
Apr 4, 2025QuVa Pharma, Inc.United StatesThe accuracy, specificity and reproducibility of test methods have not been established.
Mar 14, 2025KVK Tech, Inc.United StatesThe accuracy, sensitivity and reproducibility of test methods have not been.
Mar 7, 2025PLZ Corp.CanadaThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Feb 28, 2025Anhui Hanbon Daily Chemical Co., Ltd.ChinaThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Feb 28, 2025CELESTE INDUSTRIES CORPORATIONUnited StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Feb 18, 2025Medical Chemical CorporationUnited StatesThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Feb 14, 2025Glenmark Pharmaceuticals LimitedIndiaThe accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Feb 6, 2025Veltek Associates, Inc.United StatesThe accuracy, specificity and reproducibility of test methods have not been established and documented.

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