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    • Dr Reddys gets 8 USFDA...

    Dr Reddys gets 8 USFDA observations for Duvvada facility in Andhra Pradesh

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-08-21T10:00:11+05:30  |  Updated On 16 Aug 2021 11:39 AM IST

    The audit of Dr Reddy's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug Administration (USFDA) completed on Tuesday.


    New Delhi: The US health regulator has issued eight observations to Dr Reddy's Laboratories after the inspection of its Duvvada facility in Andhra Pradesh, the pharma major said on Tuesday.


    The audit of the company's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug Administration (USFDA) completed on Tuesday, Dr Reddy's said in a filing to the BSE.


    "We have been issued a Form 483 with 8 observations", it added.


    The company will address them comprehensively within the stipulated timeline, Dr Reddy's said.


    Read Also: Dr Reddy's unveils VERSAVO, biosimilar to Roche Avastin to treat types of cancers in India


    As per the US health regulator, "an FDA Form 483 is issued to firm 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 (FD&C) Act and related Acts."


    Read Also: VG Somani replaces Eswara Reddy as new Drugs Controller General of India


    The FDA Form 483 notifies the company's management of objectionable conditions.



    Based in Hyderabad, Dr Reddys was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.

    Read Also: Dr Reddys gets Complete Response Letter from USFDA for vaginal ring gNuvaRing: Report

    BSEDr Reddy'sDr Reddy's LaboratoriesDr Reddy's Labsdr reddys SEZ Plant 1Duvvada facilityFood Drug and Cosmeticform 483pharmapharma companypharma newspharma news indiaUS health regulatorUSFDAUSFDA form 483USFDA observationsVizag
    Source : PTI

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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