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Dr Reddy's gets 8 observations from FDA
The US health regulator 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.
Hyderabad: The US health regulator 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 United States Food and Drug Administration (USFDA) completed on Tuesday, Dr Reddy's said in a filing to the BSE.
"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 US health 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 (FD&C) Act and related Acts."
The FDA Form 483 notifies the company's management of objectionable conditions.
Meanwhile, the company has launched generic anti-epileptic Vigabatrin powder for oral solution in the US market.
The product is a generic version of Lundbeck's Sabril powder for oral solution, Dr Reddy's said.
