“The audit of the company’s Active Pharmaceutical Ingredients (API) manufacturing plant at Miryalaguda, by the United States Food and Drug Administration (USFDA), has been completed on February 21, 2017,” Dr Reddy’s Laboratories said in a filing to BSE.
The company has been issued a Form 483 with three observations, which is being addressed, it added. According to 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”.
It notifies the company’s management of objectionable conditions. Shares of Dr Reddy’s Laboratories today closed at Rs 2,899.05 per scrip on BSE, down 0.16 per cent from its previous close.