FDA Inspection 1011478 — SEAGEN INC.
The FDA completed an inspection of SEAGEN INC. on May 1, 2017 in Bothell, WA. 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
- May 1, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bothell, WA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 9093 | 21 CFR 600.80(b) | Review of Adverse Experiences - SOPs |
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |