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 » California Importer and Manufacturer Cited for Late, Incomplete MDRs

California Importer and Manufacturer Cited for Late, Incomplete MDRs

October 23, 2019

Nihon Kohden’s Irvine, California facility was written up by the FDA in a Form 483 for medical device reports (MDRs) that were late and lacked information.

In an inspection, the agency reviewed 13 MDRs for SpO2 oxyhemoglobin saturation probes. It determined that eight reports were submitted to the agency more than 30 days after the firm learned that the devices may have been involved in injuries to neonates and infants, including burns and sores.

In addition, at least 13 MDRs lacked “reasonably known” information, including patient age, date of birth, weight, ethnicity, race and relevant medical history, the agency said.

View today's stories

Medical Devices Inspections and Audits

Upcoming Events

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

  • 27May

    Evolving Clinical Trials: Continuing the Journey from Paper to Digital

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Fujifilm_Logo.gif

    Fujifilm Begins Late-Stage Trial of Avigan for COVID-19

  • CE mark

    DiaSorin’s 10-Minute COVID-19 Antibody Test CE Marked

  • WHO

    WHO Will Review Two COVID-19 Vaccines from China

  • CE mark

    Qiagen’s High Throughput COVID-19 Test Earns 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