FDA Inspection 878584 — Ophtapharm AG
The FDA completed an inspection of Ophtapharm AG on March 28, 2014 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
- March 28, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winterthur (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |