You Received an FDA Warning Letter. What Now?

Receiving a warning letter from the FDA can be a critical time for your organization as it indicates significant regulatory violations. If not properly remediated, a warning of this nature can lead to credibility concerns from customers and investors, significant fines and monetary impact, and additional enforcement escalations, including product seizures, injunctions, and criminal actions.

When you receive a warning letter, a clock starts and swift action is crucial. You’ll need to assemble the right team to provide a thorough and actionable response. Our staff at ECI has decades of experience supporting clients through this process, and we even have former FDA subject matter experts on staff who can help build valuable lines of communication directly with the Agency throughout the entire warning letter period.

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Our Approach to Warning Letter Remediation

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.

Regulatory Consultation

Our team of experts provides personalized regulatory consultation services tailored to your specific needs. We help you understand the implications of IVDR on your products and guide you through the regulatory landscape.

Product Assessment & Classification

Ensure accurate product classification under IVDR guidelines. We conduct thorough assessments of your in vitro diagnostic products, aiding in their proper classification and determining the necessary conformity assessment procedures.

Technical Documentation Review & Enhancement

Prepare and review technical documentation to meet IVDR standards. We assist in compiling, reviewing, and enhancing technical files, ensuring they align with the regulatory requirements for successful conformity assessment.

Quality Management System (QMS) Implementation

Implement a robust Quality Management System aligned with IVDR standards. Our consultants work with you to establish and enhance your QMS, ensuring it meets the stringent requirements outlined in the regulation.

Post-Market Surveillance Support

Stay vigilant with our post-market surveillance support. We help you establish and maintain effective processes for monitoring and reporting the performance of your in vitro diagnostic devices in the market.

The Benefits of ECI Solutions

Specialized Expertise

Support from former FDA staff and subject matter experts with thorough knowledge of the regulatory environment.

Independent & Unbiased Third-Party Guidance

ECI offers objective and impartial advice essential for maintaining compliance and making informed decisions without internal biases. This guidance helps ensure regulatory adherence and credibility in project execution.

Temporary Needs & Flexibility

ECI can provide the right team member at the right stage of the project. Whether you need experts to assess information, formulate FDA responses, or create systemic remediation plans, or executors to complete deliverables, our team will assign the right resource to your project.

Speed of Implementation

In most cases, ECI can start working on your project right away. This speed of service is crucial when it comes to responding appropriately to the FDA, implementing robust remediation plans, and ensuring that progress aligns with communicated timelines.

Knowledge Transfer

Our team ensures smooth knowledge transfer and best practices for internal teams during their engagement. This serves to enhance the capabilities of the existing workforce, leaving a positive impact long after our team has completed their assignment.

Focus on Core Competencies

Hiring ECI allows your internal team to focus on their core competencies and daily responsibilities, which can lead to increased efficiency and productivity within your organization.

Impact That’s Tangible

Want a closer look at how ECI supports clients in this specific area? Gain insight on how our team has helped other customers as they navigate FDA warning letter response.

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Post Market Surveillance & Vigilance Case Study

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Technology Transfer Case Study

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Technology Transfer Case Study

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Technology Transfer Case Study

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Our Strategic Services

Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Get Started Today

Contact ECI to discuss your specific requirements and learn how our solutions can guide you to FDA compliance.

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