Dr. Reddy’s facility in Andhra Pradesh gets 2 U.S. FDA observations

The U.S. Food and Drug Administration (U.S. FDA) has issued two observations to a manufacturing facility of Dr. Reddy’s Laboratories in Andhra Pradesh.

A Form 483 with the two observations was issued by the U.S. FDA on completion of a pre-approval inspection (PAI) at the company’s FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh. The inspection was conducted from October 5-7. The company will address the observations within the stipulated timeline, Dr. Reddy’s said in a filing on Thursday.

The drugmaker’s shares closed 1.86% lower at ₹1,180 on the BSE.