FDA 483 - Aizant Drug Research Solutions Private Ltd. - January 24, 2020

Aizant Drug Research Solutions Pvt. Ltd., a drug product manufacturer in Hyderabad, India, was cited with seven observations during an FDA inspection from January 20-24, 2020. The observations primarily concern deficiencies in equipment design, maintenance, cleaning, computer system controls, investigation of discrepancies, master production records, and reserve sample storage conditions. These issues indicate significant concerns regarding the firm's adherence to good manufacturing practices.