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    Cadila Healthcare gets 11 USFDA observations for St Louis facilities

    Farhat NasimWritten by Farhat Nasim Published On 2019-06-03T17:23:57+05:30  |  Updated On 13 Aug 2021 2:46 PM IST

    The United States Food and Drug Administration (USFDA) inspected the manufacturing facilities of Nesher Pharmaceuticals (USA) LLC located at St Louis, Missouri, the USA from May 13 to May 31, 2019, Cadila Healthcare said in a filing to BSE.


    New Delhi: Drug firm Cadila Healthcare Monday said the US health regulator has issued a total of 11 observations after inspection of its manufacturing facilities at St Louis in the US.


    The United States Food and Drug Administration (USFDA) inspected the manufacturing facilities of Nesher Pharmaceuticals (USA) LLC located at St Louis, Missouri, the USA from May 13 to May 31, 2019, the company said in a filing to BSE.


    Nesher Pharmaceuticals LLC is a 100 per cent subsidiary of Zydus Pharmaceuticals USA, it added.


    "The inspection concluded with 3 observations at one facility and 8 observations at the other facility of Nesher Pharmaceuticals with a recommendation for Voluntary Action Indicated (VAI)," Cadila Healthcare said.


    Also Read: Cadila Healthcare gets 14 USFDA observations for Moraiya plant


    This was a product-specific pre-approval inspection with general current good manufacturing practice (cGMP) and there were no data integrity related observations, it added.


    "The company is confident of addressing these observations and responding to the USFDA at the earliest," Cadila Healthcare said.


    As per the USFDA, VAI means that "objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action".


    Also Read: Cadila Healthcare gets EIR report from USFDA

    Cadila HealthcareCadila Pharmaceuticalscent subsidiarycompaniesCompanies based in AhmedabadEconomy of Indiafacility of Nesher PharmaceuticalsHealthcareIndiamanufacturing facilitiesMissouriNesherNesher PharmaRamanbhai PatelSt. LouisUSFDAzydusZydus Cadila
    Source : PTI

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    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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