Background

A Fortune 500 company received a Warning Letter from the FDA citing findings of device adulteration and misbranding, along with potential regulatory actions including product seizure, injunction, and civil monetary penalties. The Warning Letter followed the FDA’s determination that the company’s responses to specific FDA 483 observations were inadequate.

Regulatory Compliance Associates® Inc. (RCA) was brought in to provide leadership, subject matter expertise, and project management support to address the cited issues. Given the severity of the situation, RCA operated with a heightened sense of urgency, ensuring that remediation efforts were both timely and rigorously executed without compromising quality or compliance.

RCA 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)

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 non conformance 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 clients Quality Culture to ensure that improvements would be sustainable.

The subsequent FDA audit following the Warning Letter resulted in zero 483 observations.