1217751
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
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 |