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21 CFR 820.80(b) citations

Lack of or inadequate receiving acceptance procedures

FDA investigators cited 21 CFR 820.80(b) 667 times at 601 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 18, 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
202611
202523
202418
202331
202220
202112
202020
201941
201839
201747

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 18, 2025My Medical Store LLCUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Dec 11, 2025Mercury Enterprises, Inc.United StatesProcedures for acceptance of incoming product have not been adequately established.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Nov 21, 20253D Diagnostix Inc.United StatesProcedures for acceptance of incoming product have not been adequately established.
Nov 14, 2025Shirakawa Olympus Co., Ltd.JapanProcedures for acceptance of incoming product have not been adequately established.
Nov 12, 2025Banyan USA LLCUnited StatesAcceptance or rejection of incoming product was not documented.
Nov 12, 2025Gyrus ACMI, Inc.United StatesProcedures for acceptance of incoming product have not been adequately established.
Oct 24, 2025IRAY IMAGING LLCUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Oct 24, 2025KSL Biomedical, Inc.United StatesAcceptance or rejection of incoming product was not documented.
Oct 22, 2025LightwaveUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Oct 20, 2025McLaren FlintUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Sep 25, 2025Mollet Praezisionsmechanik AgSwitzerlandProcedures for acceptance of incoming product have not been adequately established.
Aug 26, 2025Magellan Diagnostics, Inc.United StatesProcedures for acceptance of incoming product have not been adequately established.
Aug 25, 2025Varex Imaging CorporationUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Aug 21, 2025Hoosier, IncUnited StatesAcceptance or rejection of incoming product was not documented.
Aug 8, 2025Femcap, Inc.United StatesProcedures for acceptance of incoming product have not been established.
Jul 24, 2025Medtech SASFranceProcedures for acceptance of incoming product have not been adequately established.
Jul 23, 2025VASTMED LLCUnited StatesProcedures for acceptance of incoming product have not been established.
Jul 18, 2025Microvapor Devices LLCUnited StatesProcedures for acceptance of incoming product have not been adequately established.
Jul 1, 2025Millar, Inc.United StatesProcedures for acceptance of incoming product have not been adequately established.
Jun 9, 2025CPAC Equipment, Inc.United StatesAcceptance or rejection of incoming product was not documented.
Jun 2, 2025American Contract Systems IncUnited StatesProcedures for acceptance of incoming product have not been adequately established.
May 8, 2025HAPPE SPINE, LLC.United StatesProcedures for acceptance of incoming product have not been adequately established.
Apr 16, 2025The Richline Group IncUnited StatesAcceptance or rejection of incoming product was not documented.
Mar 20, 2025MEDICREATIONS LLCUnited StatesProcedures for acceptance of incoming product have not been adequately established.

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Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

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