FDA Inspection 988922 — Samsung Bioepis Co., Ltd.
The FDA completed an inspection of Samsung Bioepis Co., Ltd. on August 19, 2016 in Yeonsu. 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 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yeonsu (Korea (the Republic of))