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 » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
%{topic} RSS Feed RSS

Centurion Draws FDA Warning Letter for Unapproved Devices

July 24, 2020
Other violations by the firm included the failure to establish procedures for corrective and preventive actions, the agency said. Read More
Quest Diagnostics logo

FDA Allows Pooled Sampling for Quest’s COVID-19 Tests

July 23, 2020
The testing strategy is most efficient in areas with low prevalence, when most results are expected to be negative, the FDA said. Read More

Greiner Bio-One Hit with Warning Letter for Quality System Violations

July 22, 2020
Greiner Bio-One neglected to finish validation testing for the qualification of a new supplier it used in the manufacturing of its Vacuette brand blood collection tubes, the agency said. Read More

FDA Warns Luminex for Validations, Process Changes

July 22, 2020
The agency received several responses, but they were deemed inadequate because they didn’t address process changes between the two heating fixtures. Read More

Nexalin Lacked Design Control Procedures, FDA Finds

July 20, 2020
Missing design control procedures for Nexalin Technology’s transcranial electrotherapy stimulator landed the firm a Form 483 following an inspection of its Houston, Texas facility. Read More

Kesair Technologies Hit for Quality System Failures

July 20, 2020
Kesair Technologies lacked proper procedures to ensure that its air sanitation devices were designed in accordance with the FDA’s quality system regulation, the agency said, following an inspection of the firm’s Kennesaw, Georgia facility. Read More

Greiner Bio-One Warned for Quality System Failures

July 20, 2020
Greiner Bio-One North America failed to complete validation testing and didn’t evaluate the effect of a manufacturing change, among other quality system failures, the FDA said in an April 16 warning letter. Read More

Luminex Draws Warning for Validations, Process Changes

July 20, 2020
Luminex started using heater fixtures produced by a new component manufacturer in 2019; however, the change was implemented without an approved validation plan, according to a June 26 warning letter. Read More

FDA Resumes Domestic Inspections Using New Risk Assessment System

July 20, 2020
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
FDA Logo device green

FDA to Resume Domestic Inspections Using New Assessment System

July 13, 2020
The agency said it aims to resume on-site inspections from July 20. Read More

FDA Releases New Program for Combination Product Inspections

July 7, 2020
The FDA has unveiled a new compliance program for inspections of combination products. Read More

483 Roundup: Three Firms Cited for Quality Failures

July 7, 2020
The FDA hit three device facilities with 483s for quality violations observed during agency inspections. Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 … 130 131 Next

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