FDA 483 - Continental Manufacturing Chemist, Inc. - July 30, 2019

Continental Manufacturing Chemist, Inc. in Madrid, IA, a manufacturer of OTC drugs and pesticides, was cited for significant deficiencies during an FDA inspection. The firm's quality control unit lacked adequate written procedures for OOS reporting, document control, and employee training, and failed to ensure proper label reconciliation and line clearance. Additionally, issues were noted with drug product storage conditions, equipment calibration, cleaning validation practices posing cross-contamination risks, and the proper handling and rejection of non-conforming and expired materials.