SEAGEN INC.June 10, 2022

FDA 483 - SEAGEN INC. - June 10, 2022

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Record Details

Seagen Inc. North Creek, a drug substance intermediate manufacturer, was cited for significant deficiencies across multiple GMP areas during an FDA inspection. Observations included inadequate microbial control procedures, insufficient risk assessments for cross-contamination, and failures in manufacturing process adherence. Additionally, the firm was found to have untimely deviation investigations, incomplete documentation of GMP operations and deviations, and inadequately maintained manufacturing equipment.

Company: SEAGEN INC.
Inspection Date: June 10, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Christopher R. Czajka (Consumer Safety Officer (Inspector))
Jacek Cieslak (Biologist)
Wendy Tan (Microbiologist)

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ID · ea221205-cb50-4ee9-9807-a41206c70bce