FDA 483 - Dr. Reddy's Laboratories Limited - March 05, 2020

Dr. Reddy's Laboratories, Ltd. - CTO 5 in Nalgonda, Telangana, India, an API manufacturer, was cited for three observations during an FDA inspection. The firm's system for reprocessing APIs and API intermediates was found insufficient, lacking proper identification, stability monitoring, and justification for reduced testing. Additionally, retest periods for reference standards were not established with supporting analytical data, and laboratory equipment, specifically HPLC columns, were not adequately qualified for USP monograph testing.