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21 CFR 820.100(a) citations

Lack of or inadequate procedures

FDA investigators cited 21 CFR 820.100(a) 4,331 times at 3,334 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 16, 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
202669
2025247
2024206
2023224
2022175
202173
2020155
2019282
2018318
2017337

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 16, 2026DASISIMULATIONS, LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Jan 16, 2026Marson Medical, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Jan 15, 2026Apex Medical Technologies, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Jan 15, 2026EPS Bio Technology Corp.TaiwanProcedures for corrective and preventive action have not been established.
Jan 15, 2026MIDWAY MEDICALUnited StatesProcedures for corrective and preventive action have not been established.
Jan 13, 2026Pleural Dynamics, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Jan 12, 2026ZIIP INCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Jan 9, 2026Welch Allyn, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Jan 8, 2026J Sterling Industries, LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 31, 2025Peter Schiff EnterprisesUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 23, 2025Edermy LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 22, 2025Ashland Specialty Ingredients, G.P.United StatesProcedures for corrective and preventive action have not been adequately established.
Dec 15, 2025MEDTRONIC GRAND RAPIDSUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 12, 2025BAND CONNECTUnited StatesProcedures for corrective and preventive action have not been established.
Dec 12, 2025Black Diamond Video Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Dec 12, 2025Foresight Imaging, LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 12, 2025MedLine Industries, LP (NAMIC Division)United StatesProcedures for corrective and preventive action have not been adequately established.
Dec 11, 2025Hatch Product Development LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 11, 2025Mercury Enterprises, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Dec 11, 2025SMCKorea (the Republic of)Procedures for corrective and preventive action have not been adequately established.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 11, 2025Thoracent, LLCUnited StatesProcedures for corrective and preventive action have not been established.
Dec 10, 20253B Medical, Inc.United StatesProcedures for corrective and preventive action have not been adequately established.
Dec 10, 2025Next Medical Products Company, LLCUnited StatesProcedures for corrective and preventive action have not been adequately established.
Dec 9, 2025Mid Central Medical, LLC.United StatesProcedures for corrective and preventive action 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.