FDA 483 - Continental Manufacturing Chemist, Inc. - May 10, 2023

Continental Manufacturing Chemist, Inc. in Madrid, IA, an OTC and animal drug product manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included a failure to perform adequate identity testing for incoming components and active pharmaceutical ingredients, a lack of appropriate laboratory determination of identity and strength for active ingredients in finished drug products prior to release, and the absence of established cleaning validation procedures for non-dedicated equipment to prevent cross-contamination. These issues indicate a systemic breakdown in ensuring product quality and safety.