FDA Inspection
Performance Health Supply LLCPerformance Health Supply LLC – FDA Inspection, Apr 17, 2019
Record Details
This FDA Inspection record concerns Performance Health Supply LLC, with an inspection on April 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5938485-2ff8-4128-8bb0-9b769cca5324
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087521
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 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 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Performance Health Supply LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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