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.
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