FDA 483 - Rusan Pharma Ltd. - May 03, 2024

Rusan Pharma Ltd., an API drug manufacturer in Ankleshwar, Gujarat, India, was cited for significant deficiencies during an FDA inspection. Observations included failures in monitoring the water system for pharmaceutical grade water and microbial contamination, lack of established time limits in master production records leading to out-of-specification results, and inadequate maintenance of manufacturing equipment with issues like rust and flaking paint on product contact surfaces. These issues indicate a lack of robust quality control and good manufacturing practices.