FDA Inspection
TPC Advanced Technology Inc.TPC Advanced Technology Inc. – FDA Inspection, Jun 11, 2019
Record Details
This FDA Inspection record concerns TPC Advanced Technology Inc., with an inspection on June 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 97e921f4-cfbc-448f-99eb-110759e00fca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092586
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of TPC Advanced Technology Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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