FDA Inspection
Performance Health Supply LLCPerformance Health Supply LLC – FDA Inspection, May 21, 2010
Record Details
This FDA Inspection record concerns Performance Health Supply LLC, with an inspection on May 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 21, 2010
- Product Type
- Devices
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ID · e9768e6e-3aea-49ab-ac8e-ff7e0a38a63a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663910
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.20(b)(5)Records of communications
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Performance Health Supply LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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