SEAGEN INC. – FDA 483, Jun 10, 2022
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.
ID · ea221205-cb50-4ee9-9807-a41206c70bce
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