1097970
Gimopharm Sarl — FEI 3010449760
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Longjumeau (France)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |