FSVP compliance that keeps your food imports clearing FDA on time
If you bring human or animal food across the border, the FDA holds you, the importer, responsible for verifying your foreign supplier. We stand up your FSVP program, put a valid DUNS on every ACE entry, and keep your product moving through Otay Mesa instead of sitting on an FDA hold.
What the Foreign Supplier Verification Program actually requires
FSVP is an FDA rule under FSMA that shifts food safety accountability onto the U.S. importer. If you are the owner or consignee of food at the time it enters the country, you are the FSVP importer of record, and you have to prove the food you bring in was produced under safety standards equivalent to U.S. requirements. That means a documented hazard analysis for each food, an evaluation of the supplier’s performance, and verification activities such as onsite audits, sampling and testing, or a review of the supplier’s food safety records.
The part that stops shipments is small and specific. Every line of every entry in ACE has to carry the FSVP importer’s name, email, and a valid DUNS number, transmitted with the correct FSVP code. If that data is missing, wrong, or points to a supplier with no program behind it, the entry can be refused and the food held. FDA also conducts FSVP inspections, usually a records request, and an importer who cannot produce a compliant file risks refusals on future entries too.
What’s included
- ✓ Confirmation of who the correct FSVP importer of record is for each product and supplier, so the right party is named at entry
- ✓ A DUNS number obtained or verified for the FSVP importer, formatted and transmitted correctly on every ACE line
- ✓ A written hazard analysis for each food covering biological, chemical, and physical hazards, including undeclared allergens
- ✓ Supplier evaluation and a matched verification activity, whether that is an onsite audit, sampling and testing, or a records review
- ✓ The FSVP records file FDA asks for, kept current and ready to produce on request
- ✓ Coordination with FDA prior notice and any PGA data your food entry also requires
- ✓ Reevaluation of suppliers on the three-year cycle, or sooner when a hazard or supplier performance changes
- ✓ A read on whether your product qualifies for an FSVP exemption, such as juice or seafood already under HACCP
How we handle it
Scope your products and suppliers
We map every food you import to its foreign supplier and confirm who legally sits as the FSVP importer of record. This settles the name, email, and DUNS that will ride on each entry.
Build the hazard analysis
For each food we identify the known and reasonably foreseeable hazards and decide which ones need a control. This is the document FDA reads first, so we write it to stand up under inspection.
Verify the supplier
We match each hazard to a verification activity that fits its risk, from onsite audits to sampling and testing to supplier records review, and we assemble the evidence into your FSVP file.
Clear entries and maintain the file
We transmit clean FSVP data on every ACE entry, respond to any FDA records request, and keep the program current through the three-year reevaluation and any supplier change.