925953
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 29, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fajardo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3138 | 21 CFR 820.130 | Packaging |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |