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    • Biocon gets USFDA Form...

    Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-09-23T10:15:20+05:30  |  Updated On 17 Aug 2021 10:14 AM IST

    "At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the new Drug Product facility and one general observation," Biocon spokesperson said in a statement.


    New Delhi: Biotechnology major Biocon on Friday said it has received a total of eight observations from the US health regulator for its two new biologics manufacturing facilities in Bengaluru.


    The United States Food and Drug Administration(USFDA) conducted a pre-approval inspection (PAI) at two of the company's new biologics manufacturing facilities in Bengaluru from Sep 10 to Sep 19, 2019, Biocon said in a filing to the BSE.


    The inspection included a new drug substance and a drug product unit, it added.


    "At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the new Drug Product facility and one general observation," Biocon spokesperson said in a statement.


    The company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously, it added.


    Read Also: Biocon Chief Kiran Shaw, FM Nirmala Sitharaman in a tiff over E-Cigarette ban


    "The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialisation plans from our existing facilities," the statement said.


    The company, however, did not provide any details about the observations made by the US regulator.


    Read Also: Biocon inks license, supply pact with CMS for 3 generic formulations

    Bioconbiocon bengaluru facilitybiologics manufacturingBSECAPACorrective and Preventive Actionform 483Kiran Mazumdar ShawKiran Shawpharmapharma companypharma newsUS health regulatorUSFDAusfda form483USFDA inspectionUSFDA observations
    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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