Home / CFR sections / 21 CFR 211.165(a)

21 CFR 211.165(a) citations

Testing and release for distribution

FDA investigators cited 21 CFR 211.165(a) 850 times at 708 facilities in the inspection citations FDA publishes, most recently in an inspection that ended May 29, 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
202616
202538
202439
202326
202237
202117
202019
201972
201849
201757

Recent citations

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

Inspection endedFacilityCountryObservation
May 29, 2026Cosmoceutical Research Center, Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
May 7, 2026Topical Pharmaceuticals, Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
May 1, 2026GVS TM, IncUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Apr 20, 2026New SPS Crossfolds, LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Mar 19, 2026PReye LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Mar 5, 2026SURETEC INNOVATIONS LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Feb 13, 2026Woodbine Products Company Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release.
Feb 12, 2026Enemeez LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Feb 6, 2026Eugia Pharma Specialities LimitedIndiaTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Jan 12, 2026Skytronics Led, IncUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Dec 22, 2025Blaine Labs IncUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Nov 20, 2025J. Strickland And CoUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Nov 19, 2025Vintage Chemical, Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
Nov 12, 2025FORDOZ PHARMA CO.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Oct 21, 2025Invicta Nutraceuticals LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
Oct 17, 2025Neutripure CorporationUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release.
Sep 29, 2025Lexia LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
Sep 19, 2025PEARMINE HEALTH LTDUnited KingdomTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
Sep 5, 2025Central Admixture Pharmacy Services, Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Aug 29, 2025Bio-Medical Pharmaceutical Manufacturing CorporationUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Jul 29, 2025Signature Formulations, LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release.
Jul 28, 2025Montgomery County Chapter Nysarc, Inc.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
Jul 16, 2025BSO LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Jul 15, 2025Stream2Sea, LLCUnited StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…
Jul 11, 2025Tower Laboratories Ltd.United StatesTesting and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior…

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