FDA Inspection 1197386 — Corden Pharma Fribourg SA
The FDA completed an inspection of Corden Pharma Fribourg SA on February 3, 2023 in Villars-Sur-Glane. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Villars-Sur-Glane (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |