FDA Inspection 1254712 — Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.
The FDA completed an inspection of Istituto Biochimico Italiano Giovanni Lorenzini S.P.A. on Nov 21, 2024 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 21, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Aprilia (Italy)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |