USFDA closes inspection of Alkem’s St Louis manufacturing facility
Alkem’s St Louis facility was inspected by the USFDA from 12 March 2018 to 16 March 2018
New Delhi: Drug firm Alkem Laboratories on 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 12 March 2018 to 16 March 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 Rs1,900 per scrip on the BSE, down 0.02% from its previous close.
(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed)
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