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USFDA finishes inspection of Alkem Lab's manufacturing facility


USFDA finishes inspection of Alkem Lab's manufacturing facility
The facility was inspected by the United States Food and Drug Administration (USFDA) from March 12, 2018, to March 16, 2018, Alkem Laboratories said in a BSE filing. (Image Credit: Twitter)

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.

The facility was inspected by the United States Food and Drug Administration (USFDA) from March 12, 2018, to March 16, 2018, Alkem Laboratories said in a BSE filing.

"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.

(With inputs from agencies.)


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