A: Our FSVP plan development includes creating a customized Foreign Supplier Verification Program tailored to your specific product, supply chain, and FDA regulatory requirements. This plan ensures that all necessary verification and compliance measures are addressed.
Q: How do you conduct a supplier risk assessment?
A: We perform a comprehensive risk assessment by evaluating the potential risks associated with each foreign supplier and their products. This involves analyzing their safety practices, historical performance, and regulatory compliance to ensure they meet U.S. food safety standards.
Q: What does regulatory compliance analysis entail?
A: Our regulatory compliance analysis involves reviewing and interpreting FDA regulations related to FSVP. We ensure that your FSVP plan aligns with these regulations, helping you avoid common pitfalls and stay compliant with current standards.
Q: How do you handle supplier verification and management?
A: We implement robust verification processes, including audits and documentation reviews, to ensure that foreign suppliers meet U.S. food safety standards. We also manage ongoing supplier relationships to maintain compliance and address any issues that arise.
Q: What kind of documentation is prepared and managed?
A: We prepare and manage essential FSVP documentation such as risk assessments, supplier verification records, import documents, and compliance reports. This ensures that all required paperwork is complete, accurate, and up-to-date.
Q: How are quality control and inspection procedures established?
A: We establish quality control measures and inspection protocols tailored to your supply chain. This includes setting standards for product quality, implementing inspection procedures, and maintaining documentation to uphold high food safety standards.
Q: What does the FSVP training program include?
A: Our FSVP training programs cover all aspects of FSVP requirements, including documentation practices, supplier management, and compliance best practices. We provide hands-on training to ensure your team is well-prepared to manage FSVP responsibilities effectively.
Q: How does the traceability system work?
A: We implement advanced traceability solutions that track products throughout the supply chain. This ensures complete product visibility and enables efficient recall management if necessary, helping you maintain compliance and safety standards.
Q: What support do you provide for CBP filings?
A: We assist with accurate and timely Customs and Border Protection (CBP) filings to ensure that your imports meet all regulatory requirements. This includes preparing and submitting necessary documentation to facilitate smooth import processes.
Q: How does ongoing compliance monitoring work?
A: Our ongoing compliance monitoring includes regular reviews of your FSVP plan and practices to ensure continuous adherence to regulatory requirements. We also provide updates and support to adapt to any changes in FDA regulations.
Q: What is involved in audit preparation and support?
A: We assist with preparing for FDA audits by developing audit plans, conducting internal reviews, and providing support during the actual audit. This includes organizing documentation, addressing audit findings, and ensuring a smooth audit process.
Q: How are corrective action plans (CAPs) developed?
A: We develop corrective action plans (CAPs) to address any gaps or non-compliance issues identified during assessments or audits. Our team helps implement these actions and verifies their effectiveness to maintain regulatory standards.
Transform your supplier management with our tailored FSVP set-up services!
