Dr. Reddy’s Gets Eight Observations From U.S. FDA For Its Duvvada Facility
The FDA Form 483 notifies the company’s management of objectionable conditions.
The U.S. Food and Drug Administration has issued eight observations to Dr. Reddy's Laboratories after the inspection of its Duvvada facility in Andhra Pradesh, the pharma major said on Tuesday.
The audit of the company's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the U.S. FDA completed on Tuesday, Dr. Reddy's said in an exchange filing.
“We have been issued a Form 483 with 8 observations,” it added.
The company will address them comprehensively within the stipulated timeline, Dr. Reddy’s said.
As per the regulator, “an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts”.
The FDA Form 483 notifies the company's management of objectionable conditions.
Shares of Dr. Reddy’s Laboratories on Tuesday closed at Rs 2,554.90 per scrip on the Bombay Stock Exchange, up 1.77 percent from its previous close.