FDA 483 - Covance Pharmaceutical R&D (Shanghai) Co., Ltd. - July 20, 2015

Covance Pharmaceutical R&D (Shanghai) Co., Ltd., a non-clinical laboratory, received two observations during an FDA inspection. The firm was cited for failing to provide separate areas to prevent contamination and mix-ups of test and control articles. Additionally, the inspection found that equipment, specifically a water purification device, was not adequately inspected, cleaned, and maintained according to the firm's own standard operating procedures.