FDA Inspection 1123653 — Richter Helm Biologics GmbH and Co KG
The FDA completed an inspection of Richter Helm Biologics GmbH and Co KG on August 28, 2019 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
- August 28, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bovenau (Germany)
Additional Details
Mutual Recognition Agreement (MRA)