1281382
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |