FDA Inspection 1193131 — Solvias AG
The FDA completed an inspection of Solvias AG on November 22, 2022 in Kaiseraugst. 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
- November 22, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kaiseraugst (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |