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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Radiation Safety Apparel Maker Fails to Report Complaints

Radiation Safety Apparel Maker Fails to Report Complaints

August 5, 2019

Devicemaker Protech Leaded Eyewear failed to develop Medical Device Reporting procedures and didn’t investigate complaints, the FDA’s Dec. 6-14, 2018 inspection of its Lake Park, Florida plant revealed.

The maker of radiation safety apparel received numerous complaints about broken lenses in its safety glasses, holes in protective gloves, and many of these “were not reviewed, evaluated or investigated. Some of these complaints, especially the glove failures, could be MDR reportable,” the Form 483 said.

The firm didn’t analyze processes, work operations, quality records, service records, complaints, returned product and other sources of quality data to identify potential causes of the nonconforming product, the FDA said.

View today's stories

Medical Devices Inspections and Audits

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

  • FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

  • FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers

  • FDA Issues EUA for Monkeypox Vaccine

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing