813241
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cayey, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |