FDA Inspection 1217751 — Samsung Bioepis Co., Ltd.
The FDA completed an inspection of Samsung Bioepis Co., Ltd. on Sep 15, 2023 in Yeonsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Yeonsu (Korea (the Republic of))
Additional details
Postmarket Adverse Drug Experience (PADE)
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 |