FDA Inspection 653276 — MedX Holdings, Inc.
The FDA completed an inspection of MedX Holdings, Inc. on March 19, 2010 in Ocala, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |