984875
Bausch Health Americas, Inc. — FEI 3009443653
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |