Hyderabad-Based Dr. Reddy’s Formulations Unit Receives 10 Observations from U.S. FDA

A Dr. Reddy's Laboratories formulations manufacturing unit in Hyderabad has received 10 observations from the U.S. Food and Drug Administration (FDA) in the form of a Form 483. This development follows a routine cGMP inspection of the facility (FTO-3) in Bachupally, conducted from October 19-27. Dr. Reddy's, in a statement on Saturday, mentioned that it will address these observations within the specified timeline. Earlier in the same month, the company received a Form 483 with nine observations from the U.S. FDA after a product-specific pre-approval inspection of their biologics manufacturing facility in Bachupally. The Form 483 is used by the FDA to inform a company's management about objectionable conditions observed during inspections that may be in violation of the Food Drug and Cosmetic Act and related Acts.