The USA Meals and Drug Administration (U.S. FDA) has issued a Kind 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 immediately accomplished a product-specific pre-approval inspection (PAI) at our formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh. The inspection was carried out from August 19-23. We’ve been issued a Kind 483 with three observations, which we’ll deal with inside the stipulated timeline,” Dr. Reddy’s mentioned in a submitting on Friday.
