Dr. Reddy’s formulations facility in AP gets 7 U.S. FDA observations

The U.S. Food and Drug Administration (U.S. FDA) has issued seven observations to Dr. Reddy’s Laboratories after an inspection of the generic drugmaker’s formulations manufacturing facility in Srikakulam, Andhra Pradesh.

“The U.S. FDA today completed a GMP and a pre-approval inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, AP. The inspection was conducted from July 10-18. We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline,” Dr. Reddy’s said in a filing on Friday.