FDA 483 - Dr. Reddy's Laboratories Ltd. - February 24, 2020

An FDA inspection of Dr. Reddy's Laboratories Ltd in Medchal Malkajgiri District, Telangana, identified significant deficiencies in control procedures for manufacturing processes. The firm failed to establish adequate procedures to monitor output and validate the performance of processes that could cause variability in in-process material and drug product characteristics. This indicates a lack of robust process control and quality assurance.