Drug firm Alkem Laboratories Tuesday said the American health regulator has issued an Establishment Inspection Report (EIR) for the company's St Louis (US) based manufacturing facility.
"In response to the Form 483 issued by the USFDA containing one observation, 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 USFDA, ALkem Laboratories said.
Shares of Alkem Laboratories today closed at Rs 1,900 per scrip on the BSE, down 0.02 per cent from its previous close.
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