FDA Inspection 1136221 — Shanghai Roche Pharmaceuticals Ltd.
The FDA completed an inspection of Shanghai Roche Pharmaceuticals Ltd. on September 6, 2019 in Shanghai. 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 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shanghai (China)
Additional Details
Mutual Recognition Agreement (MRA)