Warning Letter Remediation

SITUATION

A global medical device company received repeat 483s and a Warning Letter from the FDA. Halloran provided immediate expert regulatory and quality leadership overseeing interactions with the agency, remediation, and correction of 50+ findings.

SOLUTION

  • Developed a complete response strategy to address FDA regulatory actions
  • Managed remediation efforts
  • Executed retrospective review commitments
  • Performed quality system and regulatory requirement gap analysis
  • Prepared periodic status updates to FDA on remediation progress
  • Prepared company for /FDA follow-up inspection
  • Supported the execution of recalls, hiring of new, qualified staff, monitoring and continuous improvements of their complaint handling processes.

VALUE

Ultimately through their improved processes, the company was able to reduce their complaint volume by 81% the following year, two (2) recalls were successfully closed out with FDA, and repeat on-site inspections led to no major findings.