FDA Inspection 1137525 — Roche Diagnostics GmbH
The FDA completed an inspection of Roche Diagnostics GmbH on September 16, 2020 in Penzberg. 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 16, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Penzberg (Germany)
Additional Details
Mutual Recognition Agreement (MRA)