FDA 483 - Surmasis Pharmaceutical, LLC - March 19, 2020

An FDA inspection of Sunesis Pharmaceutical in Des Moines, IA, revealed significant deficiencies in the firm's quality control unit and its investigation processes. The company failed to adequately investigate particulate matter in drug products, out-of-specification laboratory results, and numerous environmental monitoring excursions. Additionally, procedures for preventing objectionable microorganisms were found to be inadequate.