FDA Inspection
Trevi Technology IncTrevi Technology Inc – FDA Inspection, Jun 6, 2017
Record Details
This FDA Inspection record concerns Trevi Technology Inc, with an inspection on June 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 735fac58-4f82-4883-8c0b-0b9566b30597
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1013967
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Trevi Technology Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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