FDA 483 - Dr Reddy's Laboratories Limited - December 04, 2025

An FDA inspection of Dr. Reddy’s Laboratories Limited, a drug product manufacturer in Srikakulam, India, conducted from December 4-12, 2025, identified several significant issues related to quality control and manufacturing processes. The observations detailed the firm"s failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, multiple dissolution test failures were invalidated based on unsubstantiated hypotheses and retesting, leading to the release of affected batches that were subsequently shipped to the US market. Similar issues arose with extraneous peaks in dissolution tests, and market complaints regarding incorrect tablet imprints were dismissed without adequate investigation. The inspection also highlighted deficiencies in process validation, as a tablet compression machine replacement during production was not re-qualified despite differing models, impacting various drug products destined for the US market. Furthermore, the company failed to re-validate cleaning procedures for the new equipment train, raising concerns about potential cross-contamination. Lastly, drug product release testing was found to be inadequate, as assay test methods for US-marketed products were validated using a single measurement, contrary to established internal procedures. Dr. Reddy’s Laboratories is required to implement comprehensive corrective and preventive actions to address these systemic issues and ensure full compliance with regulatory standards for drug product manufacturing.