FDA 483 - Dr. Reddy's Laboratories Ltd. - October 27, 2023

Dr. Reddy's Laboratories Ltd. received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Issues include inadequate equipment cleaning leading to product contamination, failures in laboratory equipment calibration and microbial testing methods, and a lack of thorough investigation into batch failures and consumer complaints. The firm also demonstrated poor facility maintenance and non-adherence to gowning procedures, indicating systemic quality control and compliance issues.