Continental Manufacturing Chemist, Inc. – FDA 483, 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.