FDA Inspection 1072117 — Industria Farmaceutica Galenica Senese Srl
The FDA completed an inspection of Industria Farmaceutica Galenica Senese Srl on Nov 16, 2018 in Monteroni D'Arbia. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 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 |