Business Medical Dialogues
    • facebook
    • twitter
    Sign in Signup
    • facebook
    • twitter
    Sign in Signup
    • 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
    Sign InRegister
    Business Medical Dialogues
    Sign inRegister
    • 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 closes...

    Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations

    Medical Dialogues BureauBy Medical Dialogues BureauPublished On 2019-11-02T09:45:55+05:30  |  Updated On 2021-08-16T16:01:29+05:30

    New Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for its manufacturing facility located at Daman, India after the closure of the inspection conducted by the regulator.


    The facility was inspected from August 26, 2019, to August 30 2019.


    "In furtherance to the intimation captioned "US FDA Inspection at Alkem' s manufacturing facility located at Daman, India" dated 30th August 2019, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at Daman, India which was inspected from 26th August 2019 to 30th August 2019," Alkem said in a BSE filing.


    "In response to the Form 483 issued by the US FDA containing two observations, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines," the company added.


    Read Also: Alkem Labs Bioeguivalcnce Center at Taloja clears USFDA inspection


    Alkem Labs further apprised that with respect to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at Baddi, India" dated 23rd August 2019, for the inspection conducted at the Company's manufacturing facility located at Baddi, India from 19th August 2019 to 21 August, 2019 where no Form 483 was received, an Establishment Inspection Report (EIR) has been received for the said facility located at Baddi, India and the inspection has now been closed by the 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 EIR from USFDA for St.Louis facility

    Alkem alkem facilities alkem inspection Alkem Labs Baddi CAPA Daman EIR Establishment Inspection Report form 483 USFDA USFDA form 483 USFDA inspection USFDA 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

      Johnson & Johnson Risperdal Lawsuit: US Court Slashes USD 8 Billion Verdict

      Johnson & Johnson Risperdal Lawsuit: US Court Slashes USD 8 Billion Verdict

      Covid-19 Impact: NPPA asks drugmakers to submit availablility data of 58 APIs, details

      Covid-19 Impact: NPPA asks drugmakers to submit availablility data of 58 APIs, details

      Delhi HC directs cashless service to all hospitals: GIPSA stayed on Ophthalmological Society petition

      Delhi HC directs cashless service to all hospitals: GIPSA stayed on Ophthalmological Society...

      Rising prices of hydroxychloroquine raw material forces small scale pharmas in Haridwar to stop production

      Rising prices of hydroxychloroquine raw material forces small scale pharmas in Haridwar to stop...

      Pharmaceuticals safe in PET packaging: High-level committee

      Pharmaceuticals safe in PET packaging: High-level committee

      Union Pharma Secretary Holds video conference with Pharma manufacturers and associations, takes feedback

      Union Pharma Secretary Holds video conference with Pharma manufacturers and associations, takes...

      NPPA fixes prices of 29 formulations under DPCO, check out details

      NPPA fixes prices of 29 formulations under DPCO, check out details

      Top priority on Delivery of Medicines through Speed Post: Minister

      Top priority on Delivery of Medicines through Speed Post: Minister

      View All

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

      Website Last Updated On : 29 March 2022 11:15 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

      This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
      verify here.

      Search only trustworthy HONcode health websites:

      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. © 2020 Minerva Medical Treatment Pvt Ltd

      © 2020 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      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
      X
      X