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QSR

Home » Topics » Medical Devices » QSR
  • March 8, 2018

    FDA Flags Repeat Nonconformities at Zimmer Biomet Facility

    The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana.
  • February 12, 2018

    FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet Facility

    The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections.
  • February 9, 2018

    FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet Facility

    The FDA issued a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana.
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  • January 19, 2018

    CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

  • January 18, 2018

    Warning Letter Roundup: FDA Warns Devicemakers in India, Lithuania, Texas

  • January 18, 2018

    CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

  • January 5, 2018

    FDA Warns Hand Biomechanics Over MDR, GMP Issues

  • December 29, 2017

    Warning Letter Roundup: Firms in India, Lithuania and Texas Draw Warnings

  • Redwarningstamp
    December 28, 2017

    Nurse Assist Distributed Unsterilized IV Saline Syringes, FDA Says

  • December 14, 2017

    Warning Letter Roundup: Four Firms Draw Warnings for Noncompliance

  • Fda logo blue 2016
    December 6, 2017

    Hand Biomechanics Failed to Report Serious Injuries, FDA Says

  • November 20, 2017

    FDA Warns ProSun Over Failure to Correct Tanning Bed Exposure Time

  • November 3, 2017

    FDA Warns Devicemaker Over MDR, GMP Violations

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Products

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    The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript

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    Process and Design Validation for Devicemakers – Webinar Recording/Transcript

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    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success – Webinar Recording/Transcript

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Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

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