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21 CFR 211.137(a) citations

Expiration date lacking

FDA investigators cited 21 CFR 211.137(a) 313 times at 273 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 14, 2025. 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
202512
202416
202314
20228
202111
20209
201918
201823
201714
201620

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 14, 2025University Of Pittsburgh Medical Center Centralized PackagingUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jul 28, 2025DOH Central PharmacyUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jun 16, 2025HPC VenturesUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Mar 27, 2025Owen Biosciences Inc.United StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jan 23, 2025A.P. Deauville, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jan 21, 2025NATURE'S FUSIONS, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jan 10, 2025Amish Origins Management, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jan 8, 2025Image Supply IncUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Nov 19, 2024Holi Hemp LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Nov 15, 2024HLSCIENCE CO.,LTDKorea (the Republic of)Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Oct 25, 2024Cosco International, Inc.United StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Oct 18, 2024INDUCTION THERAPIES LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Sep 25, 2024Sample Solutions, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Sep 12, 2024Rite-Kem IncorporatedUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Aug 16, 2024Chara Biologics, Inc.United StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Jun 14, 2024BOSTON NUTRACEUTICAL PRODUCTION, S.L.SpainDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
May 17, 2024Dr. G. H. Tichenor's Antiseptic CompanyUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Apr 18, 2024Applied Biologics LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Mar 22, 2024LCC Ltd.Korea (the Republic of)Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Mar 16, 2024Amorepacific CorporationKorea (the Republic of)Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Mar 15, 2024Kobayashi America Manufacturing, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Feb 9, 2024LiquidCapsule Manufacturing, LLCUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Dec 19, 2023Phoenix Wipes IncUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Dec 12, 2023Alpha AromaticsUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Dec 1, 2023Aura CaciaUnited StatesDrug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

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