KBI Biopharma, Inc. – FDA 483, Sep 28, 2020

An FDA inspection of KBI Biopharma, Inc. in Durham, NC, a drug substance manufacturer, revealed five observations primarily concerning the firm's quality unit. The findings indicate significant deficiencies in quality control unit responsibilities, data integrity controls for computerized systems, investigation and resolution of critical deviations, adherence to standard operating procedures, and employee training. These issues collectively point to a lack of robust quality system oversight and control.