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.

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Printable version | Sep 18, 2022 7:35:33 pm |