Service area
Importers & Distributors Compliance
FSVP, supplier verification and import documentation that survive an FDA records request.
- Service lines
- 9 listed
- Delivery
- Onsite and remote
- Coverage
- United States
Overview
What this covers
FSVP inspections are largely records inspections. An investigator can request your FSVP records and expect them promptly, in English, for the specific food and foreign supplier in question. Companies that keep verification evidence scattered across email threads and broker files do not fail because their suppliers are unsafe — they fail because they cannot produce the file.
We build the importer's system: written procedures, a hazard analysis per food, documented evaluation of the foreign supplier's performance and the risk posed by the food, appropriate verification activities including onsite audits where a serious adverse health consequence hazard is involved, and a corrective action process for when a supplier stops performing. For distributors and warehouses, we extend the same logic into receiving, traceability and recall execution.
Who this is for
- Importers named as the FSVP importer for human food entering the United States
- U.S. agents, brokers and buying offices whose customers depend on their compliance posture
- Distributors and wholesalers who repack, relabel, or hold food and need defensible receiving controls
- Companies importing foods on the Food Traceability List or supplying customers who demand FSMA 204 data
- Businesses that have received an FDA FSVP records request, an import alert, or a detention without physical examination
Importers & Distributors services
- FSVP
- Supplier verification
- Import documentation
- FDA inspection preparation
- Foreign supplier review
- Supplier audits
- Recall support
- Traceability
- Receiving programs
Engagements are scoped to what applies to your operation. Where a listed service is not relevant to your products, processes or jurisdiction, we will say so.
How an engagement runs
Sequenced so each step earns the next.
Nothing gets written before the operation is verified, and nothing is declared complete before it has been tested against the standard it will be judged by.
Scope and exemption analysis
Determining who the FSVP importer is for each entry line, which foods are covered, and where an exemption or modified requirement applies — for example certain juice and seafood products subject to HACCP, or suppliers in countries with a recognised or equivalent food safety system.
Hazard analysis by food
A hazard analysis for each food from each foreign supplier, identifying known or reasonably foreseeable hazards and whether they require a control. This is the foundation the verification activity has to be proportionate to.
Supplier evaluation and verification
Documented evaluation of the foreign supplier's food safety performance and compliance history, then verification activities matched to the hazard: annual onsite audit, sampling and testing, review of food safety records, or another appropriate activity with written justification.
Records, documentation and DUNS discipline
FSVP records maintained in English, retrievable on request, with the importer identification (name, address and DUNS number) transmitted correctly at entry. Small operational gaps here generate outsized problems at the port.
Traceability, receiving and recall execution
Receiving programs with defined accept/reject criteria, lot-level traceability that can produce a one-up one-back picture quickly, and a recall plan tested by a mock exercise rather than assumed to work.
Regulatory basis
The requirements behind the work.
Applicability depends on your products, processes, size and jurisdiction. Exemptions and modified requirements exist throughout these rules, and part of the engagement is establishing which apply to you.
Summaries below are educational and simplified. They are not legal advice and do not replace the text of the regulation or guidance from your regulatory authority or counsel.
- 21 CFR Part 1 Subpart L
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. Defines who the FSVP importer is, the hazard analysis and supplier evaluation obligations, verification activities, corrective actions and records requirements.
- 21 CFR Part 123 Subpart A (importer verification)
- Seafood importers have distinct verification obligations, including procedures to confirm imported product was processed in accordance with HACCP requirements. Seafood subject to Part 123 is generally exempt from FSVP for those hazards.
- 21 CFR Part 1 Subpart S (FSMA 204)
- Traceability records for foods on the Food Traceability List, including receiving records with key data elements. Applicability depends on the specific food and whether an exemption applies.
- Prior Notice — 21 CFR Part 1 Subpart I
- Advance notice of imported food shipments. Prior notice errors are a common and avoidable cause of refusal at entry, separate from FSVP.
- Import alerts and detention without physical examination
- Products or firms subject to an import alert may be detained without physical examination. Petitioning for removal is a documentation-intensive process and often warrants both technical and legal support.
Applied by industry
How this looks in practice.
The same regulatory framework produces very different programs depending on the operation it lands in.
- ImportersAs the FSVP importer you answer for hazards created in facilities you do not control. FSVP inspections are records inspections — and the file has to be producible on request.
- DistributorsDistributors rarely create hazards, but they decide whether one spreads or stops. Receiving discipline and lot-level traceability are the two controls that matter most.
- WarehousesStorage facilities are judged on pest control, temperature integrity, segregation and traceability. Third-party warehouses are increasingly audited as hard as manufacturers.
- Sushi / SeafoodSeafood carries species-specific hazards and its own federal HACCP rule. Sushi programs add acidified rice and raw consumption on top. Both draw regulatory attention.
- Private Label BrandsYour name is on the package and someone else's plant made it. Oversight of the co-manufacturer is the whole job, and a certificate on file is not oversight.
Questions we get asked
Importers & Distributors — common questions
Who is the FSVP importer if we buy through a broker?
It is the U.S. owner or consignee of the food at the time of entry, or if there is none, the U.S. agent or representative of the foreign owner who has confirmed in writing that they will serve as the importer. A customs broker filing your entry is generally not your FSVP importer. Getting this wrong at entry — including the DUNS number transmitted — is one of the most common issues we untangle.
How quickly do we need to produce FSVP records?
Promptly. FSVP records must be made available to FDA for inspection and copying upon request, and in practice investigators expect them quickly and in English. That requirement is why we build the file to be retrievable by supplier and by food rather than assuming it can be assembled on demand.
Do we need to audit every foreign supplier onsite every year?
Not necessarily. The verification activity must be appropriate to the hazard and the supplier. An annual onsite audit is specifically required where there is a reasonable probability that exposure to a hazard will result in serious adverse health consequences or death and the foreign supplier controls that hazard — unless you document an adequate written determination that other activities provide adequate assurance. For lower-risk hazards, sampling and testing or records review may be appropriate.
Related
Other practice areas
FDA & FSMA Compliance
The FDA Food Safety Modernization Act moved the regulatory burden from reacting to contamination to proving you prevented it. We build the hazard analysis, preventive controls, supplier verification and records systems that carry that burden — and we prepare your team for the inspection that tests them.
Read moreHACCP
A HACCP plan is only worth what its critical limits can be defended with. We develop, rebuild and independently review plans across seafood, juice, retail and specialized processes — including the variance and validation documentation that regulators ask for first.
Read moreDietary Supplements
Part 111 is a specification-driven rule. Most observations we see trace back to a specification that was never established, an identity test that was never performed, or a batch record that a quality unit signed without the supporting data attached.
Read more
Importers & Distributors
Tell us what you need to be ready for.
Send the operation, the products and the deadline. We will tell you which parts of importers & distributors apply to you and what it takes to be ready — in writing, before you commit.
Direct contact
- info@surucompliance.com
- 651-329-4787
- Serving food businesses nationwide, onsite and remotely.
SURU Compliance is a regulatory consulting practice. We are not a government agency, a certification body, or a law firm, and we do not provide legal advice or guarantee regulatory outcomes.