FDA Inspection 1160831 — Rentschler Biopharma SE
The FDA completed an inspection of Rentschler Biopharma SE on February 26, 2021 in Laupheim. 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
- February 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Laupheim (Germany)
Additional Details
Mutual Recognition Agreement (MRA)