FDA Inspection 1078356 — Rivopharm S.A.
The FDA completed an inspection of Rivopharm S.A. on January 18, 2019 in Manno. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manno (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |