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

Source: https://www.globalkeysolutions.net/records/483/seagen-inc/9a181ec4-9798-4d91-9a74-a92eecc9c6c8

> 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: Division of Pharmaceutical Quality Operations IV
- Summary: SEAGEN INC., a drug intermediate manufacturer in Bothell, WA, was cited for inadequate training and qualification processes for operators performing aseptic filling of PADCEV mAb intermediate. The firm's procedures failed to ensure initial proficiency and lacked periodic re-qualification for these critical aseptic operations.

## 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/2c35d8cb-a857-4b8a-ad27-b43ba4571b46)

## 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/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6