FDA 483 - Dr Reddy's Laboratories Limited - December 12, 2025

An FDA inspection conducted from December 4 to December 12, 2025, at Dr. Reddy’s Laboratories Limited, located in Srikakulam, Andhra Pradesh, India, identified significant deviations from Current Good Manufacturing Practices (CGMP). The inspection revealed five key observations. Firstly, the firm failed to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, particularly concerning dissolution test failures and extraneous peaks. Initial OOS results were often invalidated without proper root cause identification, leading to the release of affected batches to the US market. Secondly, control procedures were inadequate, specifically regarding the requalification of tablet compression machines after critical component replacements, with different make/model numbers used interchangeably without re-validation. Thirdly, written procedures for equipment cleaning and maintenance were deficient; cleaning validation was not re-evaluated after equipment changes, even when surface areas differed. Fourthly, drug product testing and release protocols were flawed. Assay methods were validated with single measurements instead of multiple as per internal procedures, and visual inspector qualification lacked defined parameters, contributing to multiple market complaints for defective and commingled products. Finally, raw material sampling practices for active pharmaceutical ingredients (APIs) were found to be scientifically unsound, failing to ensure quality and purity and contributing to OOS results in drug products. These observations necessitate immediate and comprehensive corrective actions from Dr. Reddy’s Laboratories Limited to ensure compliance with regulatory standards.