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21 CFR 820.100(b) citations

Procedures

FDA investigators cited 21 CFR 820.100(b) 1,381 times at 1,202 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 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
202612
202558
202451
202370
202239
202125
202029
201957
201867
201797

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 16, 2026Hollywog LLCUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Dec 5, 2025Bossong Hosiery Mills IncUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Nov 26, 2025Hycor Biomedical LLCUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Nov 19, 2025Blephex, LLCUnited StatesCorrective and preventive action activities and/or results have not been documented.
Nov 6, 2025Turbett Surgical, Inc.United StatesCorrective and preventive action activities and/or results have not been adequately documented.
Nov 5, 2025Drake Precision Dental LaboratoryUnited StatesCorrective and preventive action activities and/or results have not been documented.
Oct 30, 2025APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANYChinaCorrective and preventive action activities and/or results have not been adequately documented.
Oct 30, 2025Flextronics America LLCUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Oct 28, 2025New Wave Endo-Surgical, Corp.United StatesCorrective and preventive action activities and/or results have not been adequately documented.
Oct 24, 2025PADCO HOLDING COMPANY, LLCUnited StatesCorrective and preventive action activities and/or results have not been documented.
Oct 22, 2025SPOT HEALTH INCUnited StatesCorrective and preventive action activities and/or results have not been documented.
Oct 17, 2025Veolia Water Treatment & SolutionsUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Sep 25, 2025Integrity United IncUnited StatesCorrective and preventive action activities and/or results have not been documented.
Sep 25, 2025Sterigenics UK LimitedUnited KingdomCorrective and preventive action activities and/or results have not been adequately documented.
Sep 11, 2025HPF SRLItalyCorrective and preventive action activities and/or results have not been adequately documented.
Sep 8, 2025ARROW INTERNATIONAL, LLCUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Sep 4, 2025Sparsha Pharma Usa IncUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Aug 28, 2025Intersurgical Medical Apparatus (Changzhou) Co., Ltd.ChinaCorrective and preventive action activities and/or results have not been adequately documented.
Aug 21, 2025Robling Medical LLCUnited StatesCorrective and preventive action activities and/or results have not been documented.
Aug 20, 2025Pharmacaribe, LLCUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Aug 19, 2025DESIGN CATAPULT MANUFACTURING, INC.United StatesCorrective and preventive action activities and/or results have not been adequately documented.
Aug 13, 2025Nevro CorporationUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.
Aug 7, 2025RAC Medical SolutionsUnited StatesCorrective and preventive action activities and/or results have not been documented.
Jul 30, 2025Wexler Surgical, Inc.United StatesCorrective and preventive action activities and/or results have not been adequately documented.
Jul 11, 2025Best Vascular, IncUnited StatesCorrective and preventive action activities and/or results have not been adequately documented.

Search more

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.