FDA Inspection 1308746 — Oncotec Pharma Produktion GmbH
The FDA completed an inspection of Oncotec Pharma Produktion GmbH on October 17, 2024 in Dessau Rosslau. 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
- October 17, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dessau Rosslau (Germany)
Additional Details
Mutual Recognition Agreement (MRA)