FDA 483 - International Medication Systems Ltd. - December 19, 2025

International Medication Systems Ltd. in South El Monte, CA, a drug and API manufacturer, was cited with eight observations during an FDA inspection from December 9-19, 2025. The observations highlight significant deficiencies in aseptic processing environmental monitoring, equipment cleaning, laboratory controls, water system quality, and procedures for preventing microbiological contamination. Additionally, issues with DSCSA compliance and product identifier record retention were noted, indicating broad systemic failures in quality and regulatory adherence.