FDA Inspection
Padtest, LLCPadtest, LLC – FDA Inspection, Dec 21, 2015
Record Details
This FDA Inspection record concerns Padtest, LLC, with an inspection on December 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Padtest, LLC
- Inspection Date
- December 21, 2015
- Product Type
- Devices
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ID · bc9b60ea-9c8b-435e-b914-f0a2c8e29a91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953142
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Padtest, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Padtest, LLC
- FDA Inspection 1170507 - 2022-04-28
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