FDA 483 - Dr. Reddy's Laboratories Ltd. - June 21, 2019

Dr. Reddy's Laboratories Ltd. in Visakhapatnam, India, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies related to the establishment of acceptance criteria for validation activities and the lack of scientific data supporting finished product release specifications. Additionally, the firm failed to correctly translate device design into production specifications, specifically concerning Acceptance Quality Limit for component critical dimensions.