Surmasis Pharmaceutical, LLCMarch 19, 2020

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

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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.

Company: Surmasis Pharmaceutical, LLC
Inspection Date: March 19, 2020
Product Type: Drugs
Office: Chicago District Office
People: Peng Zhou
Michele L. Glendenning

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ID · cefb989e-c11c-47e4-a8d6-fed612bc523b