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    Caplin Point gets 2 USFDA observations for sterile injectable site in Chennai

    Farhat NasimWritten by Farhat Nasim   |  
    Caplin Point gets 2 USFDA observations for sterile injectable site in Chennai
    The US Food and Drug Administration (USFDA) has completed inspection of Caplin Steriles Ltd's site at Gummidipoondi in Tamil Nadu, between June 6-14, 2019.

    New Delhi: Caplin Point Laboratories on Monday said the US health regulator has made two observations after completion of inspection at its subsidiary's sterile injectable site in Tamil Nadu.

    The US Food and Drug Administration (USFDA) has completed inspection of Caplin Steriles Ltd's site at Gummidipoondi in Tamil Nadu, between June 6-14, 2019.

    At the end of this scheduled Good Manufacturing Practice (GMP) inspection, there were only two observations, Caplin Point Laboratories said in a BSE filing.

    Caplin Point Laboratories said it believes these observations are procedural in nature and corrective and "preventive actions for these observations will be presented to the USFDA shortly".


    "The observations made were not repeat observations or related to data integrity. This was the third USFDA audit at the plant since 2016," the company added.



    Caplin Point Laboratories Chairman C C Paarthipan said: "our primary focus is to ensure integrity and maintain transparency in our quality systems, and we're pleased with the result of yet another successful audit."

    Also Read: Caplin steriles signs license, supply agreement with Baxter for injectable portfolio


    BSECaplinCaplin injectable siteCaplin PointCaplin Point LaboratoriesCaplin's sterileChennaiGummidipoondiHealthcaresterilesterile injectable siteTamil NaduUSFDAUSFDA inspectionUSFDA observations
    Source : PTI

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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