FDA Inspection 1255703 — Rotop Pharmaka GmbH
The FDA completed an inspection of Rotop Pharmaka GmbH on July 2, 2021 in Dresden. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dresden (Germany)
Additional Details
Mutual Recognition Agreement (MRA)