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USFDA completes inspection at Alembic Pharma’s Panelav plant


USFDA completes inspection at Alembic Pharma’s Panelav plant

New Delhi: Drug major Alembic Pharmaceuticals said the US health regulator has conducted an inspection at its Panelav facility and has not made any observations.

“The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Panelav from April 16-23, 2018. This was a scheduled inspection and at the end of the inspection, there were zero 483s,” Alembic Pharmaceuticals said in a BSE filing.

An FDA Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related acts.

It notifies the company’s management of objectionable conditions at a facility.



Source: PTI
1 comment(s) on USFDA completes inspection at Alembic Pharma’s Panelav plant

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  1. user
    jitendra n shah April 27, 2018, 11:20 am

    very good
    alembic pharma is one of the top most pharma companies in the whole of gujarat state
    we -from sujata chemicals-wish the company & its employees all the best for the brighter future of the company
    jitendra n shah
    sujata chemicals
    baroda