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21 CFR 820.80(a) citations

Lack of or inadequate procedures - Acceptance activities

FDA investigators cited 21 CFR 820.80(a) 559 times at 510 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Nov 25, 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
20265
202536
202427
202327
202241
202116
202022
201941
201837
201740

Recent citations

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

Inspection endedFacilityCountryObservation
Nov 25, 2025Avokaid, LLCUnited StatesProcedures for acceptance activities have not been adequately established.
Nov 17, 2025Pathright Medical IncUnited StatesProcedures for acceptance activities have not been adequately established.
Oct 30, 2025Flextronics America LLCUnited StatesProcedures for acceptance activities have not been adequately established.
Oct 30, 2025Splintek, IncUnited StatesProcedures for acceptance activities have not been established.
Oct 16, 2025Homtex IncUnited StatesProcedures for acceptance activities have not been adequately established.
Sep 16, 2025Henke Sass Wolf Of America,IncUnited StatesProcedures for acceptance activities have not been established.
Sep 5, 2025Keter Canada, Inc.CanadaProcedures for acceptance activities have not been established.
Aug 25, 2025Varex Imaging CorporationUnited StatesProcedures for acceptance activities have not been adequately established.
Aug 21, 2025Hoosier, IncUnited StatesProcedures for acceptance activities have not been adequately established.
Aug 7, 2025RAC Medical SolutionsUnited StatesProcedures for acceptance activities have not been established.
Jul 31, 2025Euromi S.A.BelgiumProcedures for acceptance activities have not been established.
Jul 25, 2025Exactech Sarasota, Inc.United StatesProcedures for acceptance activities have not been adequately established.
Jun 27, 2025Ducommun Labarge TechnologiesUnited StatesProcedures for acceptance activities have not been adequately established.
May 23, 2025Somnomed IncUnited StatesProcedures for acceptance activities have not been adequately established.
May 21, 2025Macbrud CorporationUnited StatesProcedures for acceptance activities have not been adequately established.
May 9, 2025Smaart Medical Systems, IncUnited StatesProcedures for acceptance activities have not been adequately established.
May 8, 2025SPANG & BRANDS GMBHGermanyProcedures for acceptance activities have not been adequately established.
May 6, 2025AMSUSA LLCUnited StatesProcedures for acceptance activities have not been adequately established.
Apr 24, 2025Paragon 28, Inc.United StatesProcedures for acceptance activities have not been adequately established.
Apr 23, 2025R-Med IncUnited StatesProcedures for acceptance activities have not been established.
Apr 7, 2025Boston Scientific CorporationUnited StatesProcedures for acceptance activities have not been adequately established.
Mar 27, 2025dBMEDx, IncUnited StatesProcedures for acceptance activities have not been established.
Mar 21, 2025Blickman Industries LLCUnited StatesProcedures for acceptance activities have not been established.
Mar 11, 2025ISLAND DENTAL LABUnited StatesProcedures for acceptance activities have not been established.
Mar 7, 2025Healcerion Co., LTDKorea (the Republic of)Procedures for acceptance activities have not been adequately established.

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