PERFORMANCE HEALTH SUPPLY, LLC. — FDA Facility Profile
PERFORMANCE HEALTH SUPPLY, LLC. is an FDA-registered facility (FEI 2128677) located in CEDARBURG, WI, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 17, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 17, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) and 3 more |
| Apr 27, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Documentation (21 CFR 820.75(a)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 5 more |
| May 21, 2010 | Voluntary Action Indicated (VAI) | Investigation of device failures (21 CFR 820.198(c)) Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1)) DMR - not or inadequately maintained (21 CFR 820.181) Documentation (21 CFR 820.100(b)) and 1 more |
Facility details
- Company
- Performance Health Supply LLC
- Location
- CEDARBURG, WI (US)
- Source
- device