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Inspections and Audits

Home » Topics » Medical Devices » Inspections and Audits
  • January 25, 2023

    Light Age Receives Form 483 for Missing Records, CAPA Actions

    Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.

  • January 23, 2023

    Healthcare Workers Union Petitions FDA to Issue Recall of Fresenius Dialysis Machines

    The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.

  • January 19, 2023

    Ceragroup Industries Gets Repeat Form 483 Observations for CAPA and Calibration Issues

    Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration. 

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  • January 18, 2023

    Austco Lands Form 483 for Complaint Handling and Supplier Qualification

  • January 13, 2023

    iRhythm Technologies Rapped for Failing to Take Corrective Actions, Other Issues with Cardiac Monitoring System

  • January 12, 2023

    FDA Issues Two Warning Letters to Olympus for MDR Reporting, Design Violations

  • January 4, 2023

    Cytophil Rapped for Lax Validations and Testing

  • January 3, 2023

    Pedia Parents Rapped for Supplier Monitoring, Design Verifications

  • December 30, 2022

    RoyalVibe Health Gets Warning Letter for Unapproved Devices, Refusing Inspection

  • December 29, 2022

    FDA Issues Warning Letter for Unapproved COVID-19 Tests

  • December 29, 2022

    FDA Issues Warning Letter for Unapproved COVID-19 Tests

  • December 20, 2022

    CAPA Procedures Top the List of Quality Compliance Traps

  • December 20, 2022

    FDA Raps Apneicare for Recurring Inspection Observations

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Products

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    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection – Webinar Recording/Transcript

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

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

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    Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

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Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

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