1220071
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bedford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |