FDA 483 - Dr. Reddy's Laboratories Ltd. - February 08, 2019

The FDA inspection of Dr. Reddy's Laboratories Ltd. in Bachupally, Telangana, India, revealed significant deficiencies across its quality systems. Findings include inadequate complaint investigations, a lack of quality control unit authority in error investigations and product rejection, and poor controls over computer systems and data integrity. Additionally, issues were noted in master production records, laboratory controls, reserve sample representativeness, environmental conditions, facility design to prevent cross-contamination, and drainage systems.