FDA Inspection
Thermotek, Inc.Thermotek, Inc. – FDA Inspection, Jul 22, 2016
Record Details
This FDA Inspection record concerns Thermotek, Inc., with an inspection on July 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thermotek, Inc.
- Inspection Date
- July 22, 2016
- Product Type
- Devices
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ID · eecfba9c-da3a-4b2c-b09a-e87fa910dd98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981384
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Thermotek, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Thermotek, Inc.
- FDA Inspection 855517 - 2013-11-06
- FDA Inspection 677403 - 2010-08-25
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