FDA 483 - Dr. Reddy's Laboratories Limited (Unit II) - July 12, 2019

An FDA inspection of Dr. Reddy's Laboratories Limited (Unit II) in Bollaram, India, revealed significant deficiencies across multiple areas, including inadequate investigations into product quality failures and out-of-specification results. The firm also failed to effectively validate its electronic inventory management system and store raw materials under appropriate environmental conditions. Additionally, issues were noted with water system qualification protocols and the timely provision of records and qualified personnel during the inspection.