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    • Dr Reddy's gets four...

    Dr Reddy's gets four observations from USFDA for Andhra plant

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-01-19T09:30:16+05:30  |  Updated On 17 Aug 2021 11:41 AM IST


    "The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 4 observations, which we are addressing," Dr Reddy's said in a regulatory filing.


    Hyderabad: Dr Reddy's Laboratrories recently said the US health regulator has issued four observations after inspecting its formulations unit in Andhra Pradesh.


    "The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today. We have been issued a Form 483 with 4 observations, which we are addressing," the Hyderabad-based company said in a regulatory filing.


    Read Also: Dr Reddy's launches Aspirin and Dipyridamole capsules in US market


    As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.


    It notifies the company's management of objectionable conditions.





    Dr Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad, Telangana, India. The company was founded by Anji Reddy, who previously worked in the mentor

    institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India.



    Read Also: Dr Reddy's launches Sevelamer Carbonate in the US market

    Andhra plantAndhra PradeshBSEDr ReddyDr Reddys LaboratroriesDr Reddys sharesFD&C actFood Drug and Cosmetic ActHyderabadinspectionUS Food and Drug AdministrationUS health regulatorUSFDA
    Source : With input

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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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