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 » Liposuction Device Maker Receives FDA Warning Over MDR Procedures

Liposuction Device Maker Receives FDA Warning Over MDR Procedures

September 4, 2015

Belgium-based Euromi has been hit with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including cases of cannula tips from a liposuction system breaking and lodging in patients.

During a Jan. 12 to 15 inspection of Euromi’s Verviers, Belgium, facility, an FDA investigator determined the company had failed to establish procedures to ensure that complaints related to the EVA Sp liposuction system are analyzed in a timely manner.

The company also neglected to document oral complaints upon receipt, ensure that complaint investigation records contained all required information, explain why some complaints weren’t investigated and ascertain whether complaints were evaluated for MDR reportability. That final citation extended to events in which cannulae broke and fragments remained in the patient.

Euromi also failed to establish internal systems for the timely transmission of complete MDRs, including instructions for obtaining and completing a Form 3500A.

The investigator further dinged the devicemaker for not establishing procedures to ensure that all received products conform to specified requirements. For example, Euromi didn’t ensure that its contract sterilizer validated the sterilization of a disposable tubing set used with the EVA Sp6 liposuction device.

Another citation notes the firm’s corrective and preventive actions procedure doesn’t include requirements for analyzing data to determine existing and potential causes of nonconforming product or other quality problems.

“The CAPA file for nonconformance 108 (for bending problems on 2.0 mm and 2.5 mm infiltration cannulas) did not identify the batch records of the device used for testing,” the warning letter says. Euromi also failed to verify and validate the effectiveness of its corrective actions.

The firm was also cited for failing to ensure that all inspection, measuring and testing equipment is suitable for the intended purposes. For example, the tester used to analyze cannula flow contained measuring devices that hadn’t been calibrated to ensure the equipment is capable of producing valid results.

The FDA also took the company to task for not having proper control measures in place to ensure that outdated documents are removed and not unintentionally used. Euromi also failed to obtain approval dates and signatures to ensure documents were removed.

Euromi responded to the Form 483 on April 29, but the agency didn’t review it, as it wasn’t received within the required 15 business days.

The company could not be reached for comment by press time. Read the warning letter at www.fdanews.com/083115-euromi-WL.pdf.— Elizabeth Hollis

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

  • UKflag.jpg

    UK Study Says Single Shot of Pfizer/BioNTech Vaccine Significantly Lessened Asymptomatic Infections

  • emergency use authorization approved

    Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

  • FDA clears text

    Vetex Medical’s Thrombectomy Catheter Cleared by FDA

  • 100Bills_flatmoney.gif

    Merck Purchases Rights to Debiopharm’s Xevinapant for More Than $1 Billion

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