FDA Inspection 966752 — Amerx Health Care Corp.
The FDA completed an inspection of Amerx Health Care Corp. on April 8, 2016 in Clearwater, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |