612763
Dharma Research, Inc. — FEI 3010131268
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |