FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - November 17, 2014

Dr. Reddy's Laboratories Ltd., an Active Pharmaceutical Ingredient manufacturer in Srikakulam District, Andhra Pradesh, was cited for significant deficiencies across multiple areas during an FDA inspection. Issues included widespread data integrity concerns in laboratory records and computerized systems, inadequate batch production and control records, and failures in document control and training record maintenance. Additionally, the firm was cited for insufficient process validation, inadequate laboratory investigations, and unsuitable water for API manufacturing, alongside poor washing and toilet facilities.