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 July 17, 2018 in Aprilia. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 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 |