FDA Inspection
TriMed Inc.TriMed Inc. – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns TriMed Inc., with an inspection on November 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 858503fa-8d74-407c-80d9-ad3202de7e51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031588
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of TriMed Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2024 | Not classified | Los Angeles District Office | Compliance: Devices |
| August 14, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 12, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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