Warning Letter Remediation

Challenge

An Asia Pacific device company that received an FDA 483, and ultimately a Warning Letter, engaged Navigant to remediate its Quality System to bring it into compliance with FDA regulations and expectations. We assembled an expert team that traveled to the client to work side-by-side with the company’s employees for months to understand the Quality System issues and remediate them.

Solution

We approached this extremely large-scale project by breaking it out into the following workstreams, which were executed simultaneously:
  • Management Controls and Quality Systems (CAPA)
  • Design Controls
  • Complaint Handling and MDR Reporting
  • Purchasing Controls
  • Production and Process Controls
  • Regulatory Affairs
  • Independent Verification Audits
  • Statistics and Trending

Impact

 By sending our experts to the clients’ overseas facilities and working directly with company personnel, we were able to stabilize the client’s operations and forge a path forward for our client’s future success.

Risk, Regulatory and Compliance
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