FDA Inspection 1275233 — Richter Helm Biologics GmbH and Co KG
The FDA completed an inspection of Richter Helm Biologics GmbH and Co KG on June 30, 2022 in Bovenau. 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
- June 30, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bovenau (Germany)
Additional Details
Mutual Recognition Agreement (MRA)