FDA Inspection 1172380 — Oncotec Pharma Produktion GmbH
The FDA completed an inspection of Oncotec Pharma Produktion GmbH on September 3, 2021 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
- September 3, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dessau Rosslau (Germany)
Additional Details
Mutual Recognition Agreement (MRA)