FDA Inspection
Thermotex Therapy Systems LtdThermotex Therapy Systems Ltd – FDA Inspection, Nov 12, 2008
Record Details
This FDA Inspection record concerns Thermotex Therapy Systems Ltd, with an inspection on November 12, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2008
- Product Type
- Devices
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ID · a17ba09a-6c97-4a73-8d74-2278f7089407
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 551593
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Thermotex Therapy Systems Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2017 | Not classified | Office of Inspections and Investigations |
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