1042674
AJENAT PHARMACEUTICALS LLC — FEI 3033007964
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |