FDA Inspection
Performance Health Supply LLCPerformance Health Supply LLC – FDA Inspection, Apr 27, 2012
Record Details
This FDA Inspection record concerns Performance Health Supply LLC, with an inspection on April 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 27, 2012
- Product Type
- Devices
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ID · c3360101-1d10-4ab6-88ed-1e6b140f5901
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780236
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
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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 |
| May 21, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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