FDA Inspection 1192062 — Avara Liscate Pharmaceutical Services SPA
The FDA completed an inspection of Avara Liscate Pharmaceutical Services SPA on December 6, 2022 in Liscate. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Liscate (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |