FDA 483 - Dr. Reddy's Laboratories Ltd. - May 12, 2023

Dr. Reddy's Laboratory, Unit-2, a drug manufacturer in Srikakulam, Andhra Pradesh, was cited for significant deficiencies in manufacturing equipment and laboratory controls. Observations included uninstalled and unqualified commercial packaging equipment, inadequate cleaning and maintenance of production equipment, and malfunctioning API dispensing balances. Additionally, the firm failed to validate FTIR release testing methods, perform required USP Performance Verification Tests, and establish pre-use verification procedures for laboratory instruments.