FDA Inspection 1290452 — Roche Diagnostics GmbH
The FDA completed an inspection of Roche Diagnostics GmbH on May 22, 2025 in Penzberg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Penzberg (Germany)
Additional Details
Mutual Recognition Agreement (MRA)