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21 CFR 820.22 citations

Quality audits - Lack of or inadequate procedures

FDA investigators cited 21 CFR 820.22 2,151 times at 1,742 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
202629
202599
202477
202397
202283
202123
202068
2019127
2018122
2017122

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 quality audits have not been adequately established.
Jan 16, 2026Marson Medical, Inc.United StatesIndividuals who conduct quality audits have direct responsibility for the matters being audited.
Jan 13, 2026Pleural Dynamics, Inc.United StatesQuality audits have not been performed.
Jan 9, 2026Encore LaboratoryUnited StatesQuality audits have not been performed.
Dec 31, 2025Peter Schiff EnterprisesUnited StatesProcedures for quality audits have not been adequately established.
Dec 17, 2025Carolina Biological Supply CoUnited StatesIndividuals who conduct quality audits have direct responsibility for the matters being audited.
Dec 12, 2025NeuroCareAI, Inc.United StatesQuality audits and reaudits have not been performed.
Dec 11, 2025Hensler Surgical Products, LLCUnited StatesQuality audits have not been performed.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures for quality audits have not been adequately established.
Dec 9, 2025Mid Central Medical, LLC.United StatesQuality audits have not been performed.
Dec 9, 2025Moldworks Worldwide LLCUnited StatesProcedures for quality audits have not been adequately established.
Dec 4, 2025Cryo-Dynamics, Inc.United StatesQuality audits have not been performed.
Dec 3, 2025ASEPTIKITS, LLCUnited StatesQuality audits have not been performed.
Dec 2, 2025OnePacs, LLCUnited StatesProcedures for quality audits have not been adequately established.
Nov 25, 2025Avokaid, LLCUnited StatesQuality audits and reaudits have not been performed.
Nov 19, 2025Blephex, LLCUnited StatesProcedures for quality audits have not been established.
Nov 19, 2025Tobra Medical IncUnited StatesQuality audits have not been performed.
Nov 12, 2025Banyan USA LLCUnited StatesQuality audits have not been performed.
Nov 10, 2025Dualams, Inc.United StatesIndividuals who conduct quality audits have direct responsibility for the matters being audited.
Nov 6, 2025Akervall Technologies, Inc.United StatesProcedures for quality audits have not been adequately established.
Nov 5, 2025B & D Dental Corp.United StatesProcedures for quality audits have not been adequately established.
Nov 5, 2025R.G. Enterprises (U.S.A.) Inc.United StatesProcedures for quality audits have not been established.
Nov 4, 2025Tarmac Products, Inc.United StatesQuality audits were not performed at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
Oct 30, 2025Retmap IncUnited StatesQuality audits have not been performed.
Oct 30, 2025Splintek, IncUnited StatesProcedures for quality audits 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.