1099288
Emilia Resources, LLC — FEI 3003982004
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- De Kalb, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |