FDA 483 - Continental Manufacturing Chemist - July 30, 2019

During an inspection from July 22-30, 2019, Continental Manufacturing Chemist in Huxley, IA, was cited for significant deficiencies in its quality control unit, data integrity, and manufacturing processes. The firm failed to ensure proper batch release, timely investigation of OOS/deviations, and adequate control over computer systems and equipment calibration. Additionally, issues with raw material handling, vendor qualification, and cleaning validation were noted, indicating a broad lack of adherence to good manufacturing practices.