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    • Dr Reddys Srikakulam...

    Dr Reddys Srikakulam plant gets 4 USFDA observations

    Farhat NasimBy Farhat NasimPublished On 2019-10-29T10:00:17+05:30  |  Updated On 2021-08-16T12:23:56+05:30

    The audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing.


    New Delhi: Drug major Dr Reddy's on Saturday said it has received four observations from the US health regulator USFDA for its facility at Srikakulam in Andhra Pradesh.


    The audit of the company's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing.


    Dr Reddy's further said that it would address the four concerns within the stipulated timeline.


    Also Read: Dr Reddys recalls Ranitidine products in the US over cancer-causing impurity


    "The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations," said Dr Reddy's.


    It further said: "We will address them comprehensively within the stipulated timeline."


    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."


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


    Also Read: Dr Reddys gets CDSCO Committee recommendation for approval for additional indications of the Desosumab

    API Dr Reddy's Dr Reddy's Labs dr reddys Srikakulam plant drreddy slaboratories Hyderabad facility pharma pharma news pharma news india SEZ US Food and Drug Administration USFDA USFDA form 483 USFDA inspection USFDA 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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