FDA Inspection 1256189 — Shanghai Henlius Biopharmaceuticals Co., Ltd.
The FDA completed an inspection of Shanghai Henlius Biopharmaceuticals Co., Ltd. on August 18, 2023 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
- August 18, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shanghai (China)
Additional Details
Mutual Recognition Agreement (MRA)