FDA Inspection 1017293 — Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.
The FDA completed an inspection of Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. on Jul 4, 2017 in Aprilia. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 4, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aprilia (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |