Home / CFR sections / 21 CFR 820.20(c)

21 CFR 820.20(c) citations

Management review participants

FDA investigators cited 21 CFR 820.20(c) 1,137 times at 997 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 13, 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
202619
202564
202448
202359
202246
202116
202030
201960
201852
201765

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 13, 2026Pleural Dynamics, Inc.United StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
Dec 31, 2025Peter Schiff EnterprisesUnited StatesProcedures for management review have not been adequately established.
Dec 12, 2025BAND CONNECTUnited StatesProcedures for management review have not been established.
Dec 10, 20253B Medical, Inc.United StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
Dec 9, 2025Mid Central Medical, LLC.United StatesProcedures for management review have not been adequately established.
Dec 4, 2025Unetixs Vascular, Inc.United StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
Dec 3, 2025ASEPTIKITS, LLCUnited StatesProcedures for management review have not been established.
Dec 2, 2025OnePacs, LLCUnited StatesProcedures for management review have not been adequately established.
Nov 12, 2025Banyan USA LLCUnited StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
Nov 7, 2025Kerber USA Inc.United StatesProcedures for management review have not been adequately established.
Nov 5, 2025R.G. Enterprises (U.S.A.) Inc.United StatesProcedures for management review have not been established.
Nov 4, 2025Hologic, IncUnited StatesProcedures for management review have not been adequately established.
Nov 4, 2025Tarmac Products, Inc.United StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
Oct 30, 2025Retmap IncUnited StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
Oct 30, 2025Splintek, IncUnited StatesProcedures for management review have not been adequately established.
Oct 24, 2025Gergens Orthodontic LabUnited StatesManagement with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
Oct 22, 2025Conair LLCUnited StatesProcedures for management review have not been adequately established.
Oct 22, 2025LightwaveUnited StatesProcedures for management review have not been adequately established.
Oct 10, 2025Stephen Gould CorporationUnited StatesProcedures for management review have not been adequately established.
Sep 25, 2025Integrity United IncUnited StatesProcedures for management review have not been established.
Sep 25, 2025Sterigenics UK LimitedUnited KingdomProcedures for management review have not been adequately established.
Sep 19, 2025Lights' Prosthetic Eyes IncUnited StatesProcedures for management review have not been established.
Sep 19, 2025Tuxedo ImagingUnited StatesProcedures for management review have not been established.
Sep 18, 2025ANDERSEN CALEDONIA LTDUnited KingdomProcedures for management review have not been adequately established.
Sep 18, 2025VirtuSense Technologies, Inc.United StatesProcedures for management review have not been 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.