FDA 483 - Amsino Healthcare (USA) Inc - January 30, 2025

Amsino Healthcare (USA) Inc. in Vernon Hills, IL, a sterile drug and device manufacturer, was cited for numerous critical deficiencies during an FDA inspection. Observations included significant failures in aseptic processing, environmental monitoring, and quality control, leading to potential contamination and product quality issues. The report highlights inadequate investigations into discrepancies, lack of proper process controls, and ineffective corrective and preventive actions, with many issues being repeat observations from previous inspections.