Whether you import food into the United States or export to US customers, Apex builds and runs the FSVP pieces you're responsible for, so shipments clear, audits pass and FDA records requests don't turn into a scramble.
Under 21 CFR Part 1, Subpart L, the US importer must verify that each foreign supplier produces food with the same level of public health protection required of US producers. The core cycle has six parts.
You're the FSVP importer if you own or are the consignee of the food when it enters the US, or the US agent of a foreign owner who has none. We build your program and keep it running.
Confirm who the FSVP importer is for each product, which foods are exempt or eligible for modified requirements, and how many FSVPs you need.
Written hazard analysis, food and supplier evaluation, approval and verification procedures for each food and supplier, prepared under a qualified individual.
We carry out the verification your FSVP calls for: on-site supplier audits, review of supplier food safety records, and coordination of sampling and testing with an accredited lab.
Make sure every line entry carries your name, email and DUNS number, and that FSVP records are organized, translated when needed, and ready to send promptly when FDA asks.
When a supplier fails verification or FDA raises FSVP observations, we investigate, document corrective actions and help draft your response.
New suppliers added correctly, three-year reevaluations tracked and completed, and verification activities kept on schedule.
Your US customers must verify you before they can import your food. Make that easy and you win and keep US business. We prepare your facility and documents to US FDA expectations.
The complete set of documents US importers request, organized and current, so their FSVP approval takes days instead of months.
A food safety plan that meets US Preventive Controls for Human Food requirements, reviewed by a PCQI, so it lines up with what US importers and FDA expect to see.
Food facility registration and biennial renewal with your Unique Facility Identifier, and coordination with your designated US agent.
Preparation for the on-site or remote audits your US customers perform for FSVP, including a mock audit against US expectations.
Ingredient statements, Nutrition Facts and allergen declarations that meet FDA rules, including all nine major allergens. Undeclared allergens are a frequent reason for supplier corrective action under FSVP.
A recognized certificate (SQF, BRCGS, FSSC 22000) and its audit report give US importers strong evidence for their supplier evaluation. We prepare you for certification.
FSVP is the importer's legal responsibility, but it only works when the foreign supplier provides the evidence. Apex can support either side, or both.
| Requirement | US importer | Foreign supplier |
|---|---|---|
| Hazard analysis | Conducts or reviews it for each food | Shares the food safety plan and hazard analysis |
| Supplier evaluation | Evaluates procedures, compliance and history | Provides certificates, audit reports and regulatory status |
| Verification | Chooses and documents audits, testing or record review | Hosts audits, supplies records and COAs |
| Corrective action | Acts promptly, can suspend the supplier | Investigates and fixes root causes |
| Entry | Name, email and DUNS on each line entry | FDA facility registration kept current |
| Records | Keeps FSVP records and produces them on request | Keeps the source records importers rely on |
The US owner or consignee of the food at the time of entry. If there is none, it is the US agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent.
FSVP is required for each food from each foreign supplier. One supplier shipping three foods, or one food from three suppliers, means three FSVPs, although they can share documentation.
For each line entry, the FSVP importer's name, email address and a unique facility identifier recognized by FDA. FDA recognizes the DUNS number.
At least every three years, and sooner when the importer learns new information about a hazard or the supplier's performance.
Some foods are excluded or have modified requirements, including juice and seafood covered by HACCP, alcoholic beverages, certain USDA-regulated meat, poultry and egg products, and food imported for research or personal use. Very small importers and certain small foreign suppliers have modified requirements. We confirm this during scoping.
Typically your hazard analysis and food safety plan, evidence of FDA registration, a recent audit report or GFSI certificate, certificates of analysis, allergen and specification statements, and corrective action records. Having these ready as a package speeds approval.
Sources: FDA, FSMA Final Rule on Foreign Supplier Verification Programs · 21 CFR Part 1, Subpart L · Our FSVP guide
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