FDA Inspection
Thermedx LLCFDA Inspection 906905 - Thermedx LLC - December 11, 2014
Record Details
This FDA Inspection record concerns Thermedx LLC, with an inspection on December 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thermedx LLC
- Inspection Date
- December 11, 2014
- Product Type
- Devices
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ID · 2f7dbb93-cd2a-4fa6-93be-d411be38829d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 906905
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Thermedx LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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