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The US health regulator has issued eight observations to Dr Reddy’s Laboratories after the inspection of its Duvvada facility in Andhra Pradesh.
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.
“We have been issued a Form 483 with 8 observations”, the company release said.
The company said it would address them comprehensively within the stipulated timeline.
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 judgement 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.
Shares of Dr Reddy’s Laboratories on Tuesday closed at Rs 2,554.90 on the BSE, up 1.77 per cent from its previous close.
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