FDA Inspection
SEAGEN INC.SEAGEN INC. – FDA Inspection, Mar 20, 2013
Record Details
This FDA Inspection record concerns SEAGEN INC., with an inspection on March 20, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SEAGEN INC.
- Inspection Date
- March 20, 2013
- Product Type
- Drugs
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ID · c2816cca-24c7-4a54-8847-438a8d69dfb1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822857
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of SEAGEN INC.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2025 | VAI | Seattle District Office | Drug Quality Assurance |
| November 1, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 2, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 4, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for SEAGEN INC.
- FDA Inspection 1272265 - 2025-05-13
- FDA Inspection 1253880 - 2024-11-01
- FDA Inspection 1236983 - 2024-05-02
- FDA Inspection 1119141 - 2020-01-24
- FDA Inspection 1107250 - 2019-10-04
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