# FDA 483 - Partner Therapeutics Inc - July 18, 2026

Source: https://www.globalkeysolutions.net/records/483/partner-therapeutics-inc/badba9f3-2dea-4b18-bd48-2af1855d8d47

> FDA 483 for Partner Therapeutics Inc on July 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Partner Therapeutics Inc
- Inspection Date: 2026-07-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Partner Therapeutics, Inc. in Lynnwood, WA, a drug substance manufacturer, was cited for significant deficiencies in its quality control unit and document control during an FDA inspection. Observations included the quality unit's failure to approve critical operating procedures for GMP systems, a lack of adherence to written procedures for stability sample documentation, and the untimely correction of known errors in GMP forms. These issues indicate a systemic breakdown in maintaining adequate control over critical manufacturing and quality processes.

## Related Officers

- [Seneca D. Toms](https://www.globalkeysolutions.net/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)
- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/partner-therapeutics-inc/837081c1-0ffa-4c06-94c1-4ce65e130882

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822