The United States Food and Drug Administration (U.S. FDA) has issued a Form 483 with three observations to Dr. Reddy’s Laboratories after inspecting a formulations manufacturing facility of the drugmaker in Andhra Pradesh. “The U.S. FDA today completed a product-specific pre-approval inspection (PAI) at our formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh. The inspection was conducted from August 19-23. We have been issued a Form 483 with three observations, which we will address within the stipulated timeline,” Dr. Reddy’s said in a filing on Friday.
