Seagen Inc.
Overview
Seagen Inc. is a biotechnology company focusing on developing and commercializing innovative therapies for cancer treatment. Known for its pioneering work in antibody-drug conjugates (ADCs), Seagen is dedicated to improving patient outcomes in oncology.
Therapeutic areas
API / Drug Master Files
Seagen Inc. holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- PLATFORM MODULAR VIRAL CLEARANCE VALIDATION TO SUPPORT THE PURIFICATION PROCESS FOR CHO IGG1 MONOCLONAL ANTIBODIESActive2020-04-13
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832025-05-13
Training , Education , Experience overall
- 4832015-06-09
No written record of investigation
- 4832015-06-09
Procedure Deviations Recorded and Justified
- 4832015-06-09
Record maintenance 1 year (except exempt OTC)
- 4832015-06-09
Late submission of 15-day report
- 4832015-06-09
Investigations of discrepancies, failures
- 4832015-06-09
Following/documenting laboratory controls
- 4832013-03-20
Complaint Handling Procedure
- 4832013-03-20
Investigations of discrepancies, failures
- 4832013-03-20
Changes to Procedures Not Reviewed, Approved
- 4832013-03-20
Failure to develop written procedures
- 4832013-03-20
Test methods
- 4832013-03-20
Procedures not in writing, fully followed
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