FDA Inspection 881599 — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806560

The FDA completed an inspection of Roche Diagnostics GmbH on May 16, 2014 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
May 16, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Penzberg (Germany)