FDA Warning Letter Response Service

Response Program Implementation Based on 21 CFR 1.500–1.514, 117, and Related Requirements

To assist and support importers and brand owners in professionally responding to FDA Warning Letters related to FSVP compliance, supplier verification activities, labeling, food safety plans, or supply-chain controls. This service ensures the preparation of a comprehensive, corrective action response aligned with FDA requirements under 21 CFR 1.500–1.514, 117 (Subpart G), 101.3, 121, and applicable sections of 21 USC 301.

Scope of Work

Warning Letter Assessment and Consultation

Conduct an in-depth review and analysis of the FDA Warning Letter, cited violations, and operational practices. Includes a detailed consultation to gather information on current compliance systems, supplier management, food safety documentation, and historical regulatory records.

Corrective Action Plan (CAP) Development

Develop and document a detailed Corrective Action Plan (CAP) addressing each FDA observation individually, ensuring systemic correction rather than temporary fixes. Corrective actions will be designed to demonstrate sustainable compliance per 21 CFR 117 Subparts C, G, and L.

Compliance Documentation Preparation

Prepare or revise necessary compliance records and programs such as FSVP Procedures, Food Safety Plans, Supplier Verification Activities, Written Assurance Agreements, Traceability Plans, and other supporting evidence aligned with FDA expectations.

FDA Response Letter Drafting

Draft a formal Warning Letter response addressing each violation clearly and comprehensively. The letter will explain corrective actions completed, planned improvements, timelines for implementation, and supporting documentation references.

Submission Support and FDA Communications

Provide guidance for submitting the formal response letter to the FDA within the designated timeframe (typically 15 working days). Includes support for addressing any follow-up questions or requests from the FDA during the review process.

Ongoing Compliance Monitoring (Optional Add-On)

Offer periodic compliance monitoring services post-response to help maintain long-term corrective actions, ensuring ongoing alignment with regulatory requirements and preparedness for potential follow-up inspections.

Deliverables

• Comprehensive Warning Letter Analysis Report • Customized Corrective Action Plan (CAP) • FDA Warning Letter Formal Response Letter • Supporting Evidence and Updated Compliance Documentation • Corrective Action Timeline and Implementation Checklist • Optional: Compliance Monitoring Plan and Quarterly Reviews

Fees and Subscriptions

Standard Response Package – Starting at $2,950 USD

Includes:

• Warning
• Letter Analysis
• Corrective Action Plan
• Response Letter Drafting
• Compliance Documentation Preparation
• Submission Support and FDA Response Coordination

Pricing may vary based on complexity and number of violations cited as follows:

• $2,950 – 1–2 Violations (Minor Corrective Actions, No Major Systemic Revisions) • $3,950 – 3–5 Violations (FSVP Gaps, Supplier Documentation Deficiencies, or Missing Food Safety Plans) • $5,450 – 6+ Violations (Significant Systemic Non-Compliance, Multiple Suppliers/Products Involved) • Custom Quotation – Highly Complex Cases (Prior 483 Observations, Repeat Violations, Import Detentions)

Optional Annual Compliance Monitoring – $2,400 USD / year