Background

A Fortune 500 company received a FDA 483 warning letter from the FDA, reporting their findings of device adulteration and misbranding, and threatening seizure, injunction, and / or civil money penalties.

This action followed a determination by the FDA that the responses of the firm to certain observations noted on an FDA 483 were inadequate. It was clear a Warning Letter remediation strategy was missing. 

Challenge

Regulatory Compliance Associates^® Inc. was contracted to provide leadership, expertise, and project management to address the Warning Letter remediation. This critical situation required a heightened sense of urgency to ensure timely completion without sacrificing the thoroughness and integrity of the remediation.

Approach

RCA provided a team of regulatory specialists who led remediation teams in the following areas:

• Process Mapping
• CAPA Leadership
• Formal Problem Solving
• Complaint Handling
• Procedure Audits/Reviews
• Data Trending Methods & Analysis
• Independent Design Reviews
• Medical Device Reporting (MDR)

Warning Letter remediation included gap analyses, development, implementation and training of new or improved procedures, and comprehensive documentation in preparation for a follow-up audit from the FDA.

Result

Formal problem solving, corrective and preventive action (CAPA), and nonconformance data trending methods were implemented, and comprehensive documentation providing objective evidence of effective remediation was prepared. Extensive RCA leadership and coaching over several months were key in transitioning the client culture to ensure that improvements would be sustainable. The subsequent FDA audit following the Warning Letter resulted in zero 483 observations.

 

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