We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Masimo Plant Slapped With Warning Over Complaint, CAPA Violations

Masimo Plant Slapped With Warning Over Complaint, CAPA Violations

September 5, 2014

The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities.

According to an Aug. 12 warning letter posted online, Masimo received complaints regarding inaccurate readings of its Rainbow SET Pronto 7 Pulse CO-Oximeter, but the complaints were not evaluated using appropriate parameters. The company’s documented reviews didn’t identify the comparator that was used and failed to evaluate the device at the range of hemoglobin readings cited in the complaints.

The company determined that the issue was unlikely to cause or contribute to a death or serious injury, but the records of its investigation didn’t include required information regarding the nature and details of the complaints, the warning letter says.

During the Aug. 13 to Oct. 3, 2013, inspection, the FDA also found that Masimo failed to establish and maintain procedures for implementing corrective and preventive actions.

For example, the company’s CAPA didn’t address whether any manufactured product could have been affected by the manufacturing nonconformance. And it failed to explain whether a review of complaints and device history records should have been conducted to pinpoint all products possibly affected by the nonconformance, the letter says.

The FDA investigator also cited Masimo for failing to investigate the cause of nonconformities, the letter notes.

What’s the second fastest way to get a warning letter? Failing to follow FDA protocols when dealing with and processing complaints. Prevent these warning letters by purchasing Medical Device Complaint Management: A Guide for Compliance.

Medical Devices Regulatory Affairs

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing