FDA 483 - Dr Reddy's Laboratories Limited - August 23, 2024

An FDA inspection of Dr. Reddy's Laboratories Limited in Devunipalavalasa, India, revealed significant deficiencies in laboratory controls, discrepancy investigations, and computer system management. The firm failed to establish scientifically sound specifications, thoroughly review out-of-trend results and deviations, and maintain adequate controls over computer systems, indicating a lack of robust quality assurance practices.