FDA 483 - Kumar Organic Products Ltd. - June 13, 2025

Kumar Organic Products Ltd in Bangalore, India, an API manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures in quality unit responsibilities, inadequate OOS investigations and CAPAs, deficient complaint handling, poorly maintained manufacturing equipment, and an insufficient cleaning validation program. These issues indicate a systemic breakdown in ensuring product quality and safety.