1072117
Industria Farmaceutica Galenica Senese Srl — FEI 3006994492
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 16, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monteroni D'Arbia (Italy)
Citations
| ID | CFR | Description |
|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |