FDA 483 - Dr. Reddy's Laboratories Ltd, CTO Unit 1 - May 05, 2023

An FDA inspection of Dr. Reddy's Laboratories Ltd, CTO Unit 1 in Sangareddy, India, revealed a significant issue regarding the testing and storage of components. The firm failed to adequately assess storage conditions for a highly hygroscopic material, potentially impacting the quality of an active pharmaceutical ingredient. This indicates a lapse in quality control practices for raw materials.