FDA Inspection 1119623 — Ophtapharm AG
The FDA completed an inspection of Ophtapharm AG on February 28, 2020 in Winterthur. 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
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winterthur (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |