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21 CFR 820.25(b) citations

Training records

FDA investigators cited 21 CFR 820.25(b) 1,225 times at 1,053 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
202617
202565
202451
202363
202258
202119
202043
201957
201858
201766

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 training and identifying training needs have not been adequately established.
Jan 16, 2026Marson Medical, Inc.United StatesProcedures for training and identifying training needs have not been adequately established.
Dec 10, 20253B Medical, Inc.United StatesProcedures for training and identifying training needs have not been adequately established.
Dec 9, 2025Moldworks Worldwide LLCUnited StatesPersonnel training is not documented.
Dec 5, 2025Jedmed Instrument CompanyUnited StatesProcedures for training and identifying training needs have not been adequately established.
Nov 21, 2025Olympus Winter & IBE GmbhGermanyProcedures for training and identifying training needs have not been established.
Nov 20, 2025Precision Edge Surgical Products Co. LLC.United StatesProcedures for training and identifying training needs have not been adequately established.
Nov 19, 2025Blephex, LLCUnited StatesProcedures for training and identifying training needs have not been established.
Nov 19, 2025Tobra Medical IncUnited StatesProcedures for training and identifying training needs have not been established.
Nov 6, 2025Akervall Technologies, Inc.United StatesProcedures for training and identifying training needs have not been adequately established.
Nov 5, 2025PNEO, LLCUnited StatesProcedures for training and identifying training needs have not been adequately established.
Oct 29, 2025Empowered Products, Inc.United StatesPersonnel training is not documented.
Oct 24, 2025PADCO HOLDING COMPANY, LLCUnited StatesProcedures for training and identifying training needs have not been established.
Oct 21, 2025Electro Medical Systems, LLCUnited StatesPersonnel training is not documented.
Oct 20, 2025McLaren FlintUnited StatesProcedures for training and identifying training needs have not been adequately established.
Oct 16, 2025Homtex IncUnited StatesProcedures for training and identifying training needs have not been adequately established.
Oct 16, 2025VENTURE SOLUTIONSUnited StatesProcedures for training and identifying training needs have not been established.
Sep 26, 2025Moebius Precision CorporationUnited StatesProcedures for training and identifying training needs have not been adequately established.
Sep 22, 2025Aerin Medical, Inc.United StatesPersonnel training is not documented.
Sep 19, 2025Tuxedo ImagingUnited StatesProcedures for training and identifying training needs have not been established.
Sep 18, 2025VirtuSense Technologies, Inc.United StatesPersonnel training is not documented.
Sep 4, 2025Orchid Orthopedics Switzerland GmbHSwitzerlandProcedures for training and identifying training needs have not been established.
Aug 22, 2025Activbody, Inc.United StatesProcedures for training and identifying training needs have not been adequately established.
Aug 15, 2025Minnesota MedTec, Inc.United StatesProcedures for training and identifying training needs have not been adequately established.
Aug 8, 2025Audicon CorporationUnited StatesProcedures for training and identifying training needs 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.