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 November 21, 2024 in Aprilia. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 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 |