FSVP Agent & Product Assessments
FSVP Agent Services to foreign imports of Medical Devices, Cosmetics, Dietary Supplements, and Food
Under the Foreign Supplier Verification Program (FSVP), U.S. importers are responsible for ensuring that their foreign suppliers meet FDA food safety standards. The FSVP rule, part of the Food Safety Modernization Act (FSMA), requires U.S. importers to verify that the food they bring into the U.S. meets the same safety standards as domestically produced food. Unlike traditional customs import requirements, FSVP is an ongoing responsibility that involves monitoring and verifying supplier compliance.
The FDA mandates that medical device importers and dietary supplement importers must verify that foreign suppliers comply with U.S. safety standards. This includes verifying that the supplier’s manufacturing processes meet Good Manufacturing Practices (GMP) and that their products are free from contamination and accurately labeled.
Assistance for US importers
We also provide services for US importers of food products to help them meet the FDA FSVP requirements. Our services include establishing policies for foreign supplier verification and handling foreign supplier verification-related activities. Please get in touch with us for more details.
Acting as Your Designated FSVP Agent
- If you are a foreign supplier shipping food products to the U.S., you must designate a U.S.-based FSVP Agent to represent you. We act as your official FSVP Agent, managing supplier compliance, record-keeping, and communication with the FDA.
- Serving as your official FSVP Agent for compliance and audits
- Handling FDA inquiries and supplier verification documents
- Ongoing monitoring and reporting of foreign supplier compliance
- Support for FDA inspections and enforcement actions
Supplier Compliance Assessments
- FSVP requires U.S. importers to verify that their foreign suppliers follow FDA safety standards. We conduct supplier compliance assessments to ensure your products meet U.S. regulations before importation.
- Reviewing supplier food safety and hazard control plans
- Verifying compliance with GMP and HACCP standards
- Ensuring proper record-keeping and documentation for FDA audits
- Evaluating supplier corrective action plans (CAPs) for previous violations
- GMP verification for medical device and cosmetic manufacturers
Product Assessments for FDA Compliance
- Before you import food, beverages, or dietary supplements, we conduct a comprehensive product assessment to ensure compliance with FDA standards. This prevents detentions, refusals, and costly delays.
- Ingredient safety and allergen assessment
- Label review for compliance with FDA food labeling laws
- Evaluation of food safety risks and hazards
- Verification of claims (e.g., organic, non-GMO) for regulatory approval
Import Documentation & FDA Prior Notice Support
- Proper documentation is key to avoiding shipment delays and FDA detentions. We ensure your import documentation meets all FSVP and FDA prior notice requirements.
- Full FDA Prior Notice submission assistance
- Review of bill of lading, commercial invoices, and packing lists
- Verification of supplier food facility registration status
- Assistance with Customs and Border Protection (CBP) coordination
Corrective Actions for FDA Non-Compliance
- If your foreign supplier has been cited for FSVP violations or FDA import refusals, we help you implement corrective actions to regain compliance and resume importing.
- Developing and submitting Corrective Action Plans (CAPs) to the FDA
- Working with foreign suppliers to improve food safety programs
- Assisting with FDA re-inspection and compliance audits
- Re-evaluating supplier verification programs for ongoing compliance
- Root cause analysis to identify compliance issues
- Re-submission of documentation to FDA for import clearance
FDA Inspection & Audit Readiness Support
- The FDA conducts routine inspections to verify FSVP compliance. We provide pre-inspection preparation and audit support
- Mock FDA inspections to prepare importers for regulatory reviews
- Assistance with FDA Form 483 responses and corrective actions
- Pre-inspection readiness audits to identify compliance gaps
- Audit-ready compliance reports for FDA reviews
- Tracking of supplier verification and compliance history
FSVP Initial Assessment Form
The fee for FSVP agent services depends on the product and expected annual sales volumes in the United States. In order to send you a proposal for FSVP agent services, please complete the below form, and one of our representatives will get back to you as soon as possible.