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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

  • Jessica ringel 600green

    Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

    $287.00
  • Pamela forrest  500aqua

    Medical Device Reporting: Best Practices and Common Pitfalls – Webinar Recording/Transcript

    $287.00
  • Kristen grumet 600red

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

    $287.00
  • Davidlchesney aqua500

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

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Events

  • 24May

    Quality Culture: You Can’t Improve What You Don’t Measure — Practical, Innovative Diagnostic Tool Allows Companies to Measure and Improve Their Quality Culture

  • 09Jun

    How to Standardize your Lab Investigation Process: Increase Efficiency and Reduce Risk with a Consistent Process

  • 21Jun

    Medical Device Reporting: Best Practices and Common Pitfalls

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