U.S. FDA observations for Dr. Reddy’s facility 


The United States Food and Drug Administration (USFDA) has issued a Form 483 with two observations to Dr. Reddy’s Laboratories following an inspection of the company’s formulations facility (FTO-11) in Srikakulam, Andhra Pradesh.

A pre-approval inspection (PAI) had been conducted from June 30-July 7. “We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,” Dr. Reddy’s said in an intimation to the stock exchange on Thursday evening.

Source link

Leave a Response