# FDA 483 - SEAGEN INC. - May 13, 2025

Source: https://www.globalkeysolutions.net/records/483/seagen-inc/2c35d8cb-a857-4b8a-ad27-b43ba4571b46

> FDA 483 for SEAGEN INC. on May 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SEAGEN INC.
- Inspection Date: 2025-05-13
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of SEAGEN INC. in Bothell, WA, a drug intermediate manufacturer, identified deficiencies in the training and qualification process for operators performing aseptic filling of PADCEV mAb intermediate. The firm's qualification procedures were found to be inadequate in both initial training and evaluating continued proficiency, including the use of commercial lots for final qualification and a lack of periodic re-qualification requirements. These issues indicate a potential risk to product quality and patient safety.

## Related Documents

- [483 - 2022-06-10](https://www.globalkeysolutions.net/records/483/seagen-inc/ea221205-cb50-4ee9-9807-a41206c70bce)
- [483 - 2025-05-13](https://www.globalkeysolutions.net/records/483/seagen-inc/9a181ec4-9798-4d91-9a74-a92eecc9c6c8)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913