# FDA 483 - SEAGEN INC. - June 10, 2022

Source: https://www.keypedia.com/records/483/seagen-inc/ea221205-cb50-4ee9-9807-a41206c70bce

> FDA 483 for SEAGEN INC. on June 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SEAGEN INC.
- Inspection Date: 2022-06-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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## Related Officers

- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Jacek Cieslak, PhD, Biologist](https://www.keypedia.com/people/jacek-cieslak-phd-biologist/59683a5f-277f-41b8-be10-0dc82b7596f3)

Company: https://www.keypedia.com/companies/seagen-inc/07c5dcb3-661e-4212-adfc-a00316850e38

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd