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    Alkem Labs gets EIR from USFDA for its Daman facility

    Written by Ruby Khatun Khatun   |  

    New Delhi: Drug firm Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its Daman facility.


    Company's manufacturing facility at Daman was inspected from March 19 to March 27, 2018, by the United States Food and Drug Administration (USFDA), Alkem Laboratories 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 health regulator, Alkem Laboratories said.

    13 observationsAlkem LaboratoriesAlkem LabsCAPACorrective and Preventive ActionDaman facilityEIREstablishment Inspection Reportform 483United States Food and Drug AdministrationUSFDA
    Source : PTI

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    Ruby Khatun Khatun
    Ruby Khatun Khatun
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