FDA Inspection 1103444 — Roche Diagnostics GmbH
The FDA completed an inspection of Roche Diagnostics GmbH on August 29, 2019 in Mannheim. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mannheim (Germany)