Partner Therapeutics Inc – FDA 483, Jul 18, 2022

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.