Alkem Labs gets EIR from USFDA for its Daman facility

Press Trust of India  |  New Delhi 

Drug firm today said the US regulator has issued an establishment inspection report (EIR) for its facility.

Company's at was inspected from March 19 to March 27, 2018, by the Food and Drug Administration (USFDA), said in a filing to BSE.

"In response to the Form 483 issued by the USFDA containing 13 observations, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines," it added.

The inspection has now been closed by the US regulator, said.

Shares of Alkem Laboratories today closed at Rs 2,026.35 per scrip on BSE, up 7.65 per cent from its previous close.

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First Published: Tue, July 24 2018. 17:15 IST