Skip to content

Share

  • Add this article to your LinkedIn page
  • Add this article to your Twitter feed
  • Add this article to your Facebook page
  • Email this article
  • View or print a PDF of this page
  • Share further
  • Add this article to your Pinterest board
  • Add this article to your Google page
  • Share this article on Reddit
  • Share this article on StumbleUpon
  • Bookmark this page
CLIENT STORY

Global medical diagnostics firm – overcoming failure of the quality system following an FDA 483

The North Carolina facility of a global medical diagnostics firm is dedicated to the production and packaging of reagents. The facility had performed poorly during recent FDA inspections, culminating in a listing of 26 audit observations.

With a Warning Letter looming, corporate management engaged PA Consulting Group for assistance with mounting an effective program to address the FDA’s findings and prepare the site for re-inspection.

PA delivered successful action responding to the 483.

After four weeks, all 151 corrective and preventive action projects were in control and 62%  were complete.

This allowed the company to initiate proactive progress review sessions with the FDA. 

To find out more about how we can help you with your quality systems, please contact us now.

Contact the technology innovation team

By using this website, you accept the use of cookies. For more information on how to manage cookies, please read our privacy policy. 

×