1179756
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lexington, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |
| 9096 | 21 CFR 600.80(c)(1)(ii) | Reporting Requirements - 15-day alert follow up |