FDA 483 - Dr. Reddy's Laboratories Ltd. - October 29, 2021

Dr. Reddy's Laboratories Ltd. in Duvvada, India, a sterile drug manufacturer, was cited for significant deficiencies across its quality control unit, laboratory controls, environmental monitoring, and aseptic process validation. The inspection revealed a systemic lack of scientifically sound procedures, inadequate validation, and failure to follow established protocols. These issues indicate a high severity of non-compliance, impacting the assurance of sterile drug product quality and purity.