You Received an FDA Warning Letter. What Now?

Acknowledgement

Upon receiving a warning letter, clients should notify the Agency of their intent to respond within 15 business days.

Assemble Response Team

Lean on our guidance and regulatory expertise as you respond to your FDA warning letter. We’ll connect you with subject matter experts who have a comprehensive understanding of the problems cited and a clear plan for how to effectively address them.

Remediation Execution

Remediation activities often stretch a company’s capacity, and it can be extremely challenging to continue day-to-day operations while also addressing FDA commitments in a timely manner. ECI’s team of SMEs, Project Managers, Engineers, and Regulatory Affairs and Quality Consultants are available to support remediation commitments until compliance solutions are achieved.

Creation of Quality/CAPA Plan

ECI can provide a roadmap and actionable CAPA/Quality Plan for each observation cited in the warning letter. We’ll also help provide a realistic and achievable timeline associated with each remediation activity, which is critical as these efforts are closely monitored by the Agency.

FDA Meeting/Updates

With former FDA consultants on staff, ECI can help facilitate a positive working relationship between the client and the FDA during the warning letter remediation process. We also offer on-going client support by providing accurate and timely updates and ensuring smooth collaboration with the Agency.