1153931
Denver Solutions, LLC — FEI 3013438582
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 7, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |