Create a tailored Foreign Supplier Verification Program (FSVP) plan that aligns with FDA regulations and meets your specific product and supply chain needs.
Comprehensive Supplier Risk Assessment
Conduct thorough risk assessments to identify and evaluate potential risks associated with your foreign suppliers and their products.
Regulatory Compliance Analysis
Analyze and interpret FDA regulations to ensure your FSVP plan meets all required compliance standards and avoids regulatory pitfalls.
Supplier Verification and Management
Implement robust verification processes for foreign suppliers to confirm their adherence to U.S. food safety standards and regulatory requirements.
Documentation Preparation and Management
Prepare and manage essential FSVP documentation, including risk assessments, verification records, and import documentation to support compliance.
Quality Control and Inspection Procedures
Establish quality control measures and inspection protocols to maintain high food safety standards throughout your supply chain.
FSVP Training Programs
Provide targeted training for your team on FSVP requirements, documentation practices, and best practices for managing foreign suppliers.
Traceability System Implementation
Implement advanced traceability solutions to ensure complete product tracking and effective recall management if needed.
Customs and Border Protection (CBP) Filing Assistance
Ensure accurate and timely CBP filings to facilitate smooth and compliant import processes.
Ongoing Compliance Monitoring
Offer continuous monitoring and support to ensure ongoing adherence to FSVP requirements and adapt to any regulatory changes.
Audit Preparation and Support
Assist with preparing for FDA audits, including developing audit plans, conducting internal reviews, and supporting during the actual audit.
Corrective Action Plan (CAP) Development
Develop and implement corrective action plans for any identified gaps or non-compliance issues to maintain regulatory standards.
