1115004
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |