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 » Irish Devicemaker’s 483 Notes Rusty Tables in Clean Room

Irish Devicemaker’s 483 Notes Rusty Tables in Clean Room

June 27, 2014

Natus Manufacturing Limited, an Irish devicemaker, received an FDA Form 483 for slips related to acceptance activities and contamination-prevention procedures.

The FDA investigator observed rusty tables, cabinets and other equipment in the company’s clean room near the packaging area. The automated needle electrode assembly machine had “chipped paint all around its surface,” according to the form, recently released.

Natus also had multiple air microbial failures in the clean room in 2013 and in 2012, the form says.

In a second observation, the FDA notes Natus lacked statistical rationale to justify its sampling method for acceptance activities, including in-process inspection and finished device inspection for needle electrodes.

Natus did not respond to a request for comment by press time.

Avoid a 483 and train your employees in house on FDA quality system requirements and procedures by Quality Systems Training for Devicemakers.

Medical Devices Inspections and Audits

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • CE mark

    MiRXES Earns CE Mark for COVID-19/Flu Test

  • KitePharma_Logo

    Kite Pharma’s Tecartus Gains UK Recommendation for Lymphoma

  • Eli Lilly logo

    Lilly’s Monoclonal Antibody Could Prevent COVID-19 in the Elderly

  • CE mark

    Fluidigm Gains CE Mark for Saliva-Based Assay for COVID-19

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