The United States Food and Drug Administration (U.S. FDA) has issued a Form 483 with 4 observations to a formulations manufacturing facility of pharma main Dr. Reddy’s Laboratories in Srikakulam, Andhra Pradesh. The observations adopted an inspection of the ability (FTO SEZ PU2). It was a product-specific pre-approval inspection and a routine GMP inspection and carried out from May 8-12. “We have been issued a Form 483 with four observations, which we will address within the stipulated timeline,” Dr. Reddy’s stated in an intimation to the inventory trade.
