FDA Inspection
Trevi Technology IncTrevi Technology Inc – FDA Inspection, Nov 6, 2018
Record Details
This FDA Inspection record concerns Trevi Technology Inc, with an inspection on November 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f387485-7526-491f-887d-1cb755d0bc8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072317
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Trevi Technology Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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