FDA Inspection 993047 — Anewmed Corporation
The FDA completed an inspection of Anewmed Corporation on October 18, 2016 in Tucker, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tucker, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3837 | 21 CFR 820.25(b) | Training records |