FDA Inspection 1217751 — Samsung Bioepis Co., Ltd.
The FDA completed an inspection of Samsung Bioepis Co., Ltd. on September 15, 2023 in Yeonsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Yeonsu (Korea (the Republic of))
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 9099 | 21 CFR 600.80(c)(1)(iii) | Reporting Requirements - submission of reports |