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 » FDA’s Top GMP Inspection Findings for FY 2019

FDA’s Top GMP Inspection Findings for FY 2019

FDA_Logo_Blue_2016.gif
September 27, 2019

An FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles.

Failure to document quality unit responsibilities and procedures was once again the top citation in the agency’s Form 483 reports. It’s been the top citation for over a decade — often by a wide margin.

This year, the agency logged 185 instances of the violation, 50 more times than the second most frequent GMP lapse, which was failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications. The agency observed that failure 135 times compared to 107 in 2018, moving it up from third to second place.

View today's stories

Pharmaceuticals 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

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives 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