Express Pharma

US FDA to re-audit Dr Reddy’s three plants

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The plants are located at Srikakulam, Miryalaguda and Duvvada

US Food and Drug Administration (US FDA) will re-audit three manufacturing facilities of Dr Reddy’s Laboratories in the current quarter.

The US FDA had issued a warning letter to the drug major on November 5, 2015 on three of its plants at Srikakulam, Miryalaguda and Duvvada after finding several violations with regard to current good manufacturing practices (CGMP).

US FDA had inspected the plants in November 2014, January and February 2015, respectively. “Re-audit has been scheduled for first quarter of 2017,” the Hyderabad-based company said in a presentation on its website. All the commitments as part of the warning letter response have been completed, it added.

The company said it first submitted response regarding the warning letter to the US FDA in December 2015 and gave final status update on the matter in August 2016.

In a BSE filing, the company today said that “scheduling of audit by the US FDA is a usual activity in the normal course of pharmaceutical industries’ business operations”.

 

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