Home / CFR sections / 21 CFR 820.80(e)

21 CFR 820.80(e) citations

Maintained as part of the DHR {see also 820.184}

FDA investigators cited 21 CFR 820.80(e) 352 times at 327 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 27, 2025. 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
20261
20258
20248
202310
20227
20214
20202
201918
201826
201724

Recent citations

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

Inspection endedFacilityCountryObservation
Oct 27, 2025RG Medical USAUnited StatesAcceptance activities were not documented and maintained as part of the device history record.
Sep 26, 2025Slater Endoscopy, LLCUnited StatesAcceptance activities were not adequately maintained as part of the device history record.
Apr 10, 2025HERSILL, S.L.SpainAcceptance activities were not documented.
Mar 5, 2025OMT, LLCUnited StatesAcceptance activities were not adequately maintained as part of the device history record.
Jan 16, 2025Avalign Instruments & ImplantsUnited StatesAcceptance activities were not adequately documented.
Dec 19, 2024Specialty Vision LlcUnited StatesAcceptance activities were not documented.
Dec 4, 2024ARCH Medical Solutions - WarsawUnited StatesAcceptance activities were not adequately documented.
Nov 20, 2024Stridelink IncUnited StatesAcceptance activities were not adequately documented.
Nov 15, 2024Pace Tech, Inc.United StatesAcceptance activities were not documented and maintained as part of the device history record.
Sep 16, 2024Rockwell Medical, Inc.United StatesAcceptance activities were not maintained as part of the device history record and adequately documented.
May 31, 2024Robbins Instruments, LLCUnited StatesAcceptance activities were not adequately documented and adequately maintained as part of the device history record.
Mar 28, 2024AB MEDICA SASFranceAcceptance activities were not adequately documented.
Mar 20, 2024Distron CorporationUnited StatesAcceptance activities were not adequately documented.
Mar 19, 2024Chitogen, Inc.United StatesAcceptance activities were not maintained as part of the device history record and adequately documented.
Mar 1, 2024Electro Cap International IncUnited StatesAcceptance activities were not documented and adequately maintained as part of the device history record.
Feb 20, 2024E. Benson Hood Laboratories, Inc.United StatesAcceptance activities were not documented.
Oct 18, 2023J&T Health And Wellness LLCUnited StatesAcceptance activities were not adequately maintained as part of the device history record.
Aug 24, 2023R A Medical ServicesUnited KingdomAcceptance activities were not maintained as part of the device history record and adequately documented.
Jun 29, 2023Boston Brace International IncUnited StatesAcceptance activities were not adequately documented.
Jun 26, 2023Zuga Medical Inc.United StatesAcceptance activities were not adequately documented.
Jun 22, 2023Pharmasept Medical Products 1995 Ltd.IsraelAcceptance activities were not adequately documented.
Jun 22, 2023Techlem Medical CorporationCanadaAcceptance activities were not adequately documented and adequately maintained as part of the device history record.
Jun 8, 2023Proxtalker.Com, LlcUnited StatesAcceptance activities were not documented and maintained as part of the device history record.
May 12, 2023JMS Healthcare PHL Inc.PhilippinesAcceptance activities were not documented.
Mar 17, 2023USA Facemask LLCUnited StatesAcceptance activities were not adequately maintained as part of the device history record.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.