FDA Inspection 822857 — SEAGEN INC.
The FDA completed an inspection of SEAGEN INC. on Mar 20, 2013 in Bothell, WA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 20, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bothell, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |