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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.

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Mark Humphries
Product development and manufacturing
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