FDA Inspection 1059331 — Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.
The FDA completed an inspection of Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. on Jul 17, 2018 in Aprilia. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aprilia (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |