FDA EIR - Dr. Reddy's Laboratories Ltd. - October 30, 2018

An FDA inspection of Dr. Reddy's Laboratories Ltd. in Duvvada, India, was conducted from October 22-30, 2018. This was a targeted inspection, following a previous "Official Action Indicated" classification in 2017, focusing on sterile injectable and potent drug products. The inspection assessed compliance with current Good Manufacturing Practices (cGMP) under federal regulations governing drug manufacturing and distribution.The inspection uncovered significant and persistent objectionable conditions, notably a failure to adequately address deficiencies from prior inspections; five of the eight critical issues were repeated. Key violations included inadequate controls for ensuring the quality of distributed injectable drug products, and incomplete investigations into out-of-specification (OOS) results and equipment defects impacting product batches. Aseptic process simulation (media fill) procedures were deemed inadequate, failing to represent routine operations or simulate critical interventions effectively. Other concerns involved an insufficient microbiological monitoring program, improper filters in validation studies, and deficient airflow studies. The firm also failed to implement effective preventative actions for recurring laboratory events, operated with an inadequate training program, and had incomplete batch production records, alongside a late submission of a Field Alert Report.Dr. Reddy's management committed to implementing corrective actions, conducting a comprehensive impact assessment, and temporarily halting distribution of specific lots of Docetaxel Injection and Sirolimus Tablets. A formal written response detailing these actions was promised to the FDA within fifteen business days for evaluation.