Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • Alkem Labs gets EIR...

    Alkem Labs gets EIR from USFDA for St.Louis facility

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-09-12T09:30:07+05:30  |  Updated On 16 Aug 2021 12:55 PM IST

    "In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019, this is to inform you that USFDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at St. Louis, Fenton Logistics Park, USA," Alkem Labs said in a filing.


    Mumbai: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the US health regulator has issued an Establishment Inspection Report (EIR) for its manufacturing facility at St. Louis, Fenton Logistics Park, USA.


    The facility was inspected from August 16, 2019, to August 22, 2019, and where the Company received a Form 483 issued by the United States Food and Drug Administration (USFDA) containing four observations.


    The inspection has now been closed by the USFDA. However, the drugmaker has been issued an EIR.


    "In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019, this is to inform you that USFDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at St. Louis, Fenton Logistics Park, USA," Alkem Labs said in a filing.


    Medical Dialogues had earlier reported that the Alkem Labs had received a Form 483 with four (4) observations for the facility located at St. Louis, Fenton Park, USA. Commenting on the observations, Alkem Labs had stated, "The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations for the facility located at St. Louis, Fenton Park, USA and the same is proposed to be filed within the timeline stipulated by US FDA."


    Established in 1973, Alkem Laboratories has a portfolio of over 700 brands covering all major therapeutic segments. It has 16 manufacturing facilities, 14 being in India and two in the United States.

    Read Also: Alkem Labs gets 4 USFDA observations for St Louis facility

    AlkemAlkem BaddiAlkem LabsAlkem manufacturing facilitiesAlkem US plantbaddi facility.EIREstablishment Inspection Reportform 483pharmapharma companypharma newspharma news indiaUSFDAusfda 483USFDA form 483USFDA inspectionUSFDA observations

    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

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      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

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      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. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok