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    • Alembic Pharma gets 3...

    Alembic Pharma gets 3 observations from USFDA for Gujarat plant

    Written by Ruby Khatun Khatun Published On 2018-03-22T11:30:46+05:30  |  Updated On 22 March 2018 11:30 AM IST
    Alembic Pharma gets 3 observations from USFDA for Gujarat plant

    New Delhi: Alembic Pharmaceuticals said the US health regulator has made three observations after inspecting its formulation facility in Panelav, Gujarat.


    "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals formulation facility located at Panelav from March 12-20, 2018. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 3 observations," the company said in a regulatory filing.


    Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature.


    "The company is preparing the response to the observations, which will be submitted to the USFDA shortly," it added.


    As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.


    It notifies the company's management of objectionable conditions.

    3 observations483 observationAlembic PharmaAlembic PharmaceuticalsFood Drug and Cosmetic Actform 483formulation facilityGujaratGujarat plantinspectionPanelavUnited States Food and Drug AdministrationUSFDA
    Source : PTI

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    Ruby Khatun Khatun
    Ruby Khatun Khatun
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