1074810
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carteret, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |