Most companies importing food into the United States underestimate how costly it can be to misunderstand a single term in the Foreign Supplier Verification Program (FSVP). Few terms cause more confusion—or more enforcement issues—than the identity of the FSVP Importer. FDA investigators consistently report that facilities fail audits not because they lack documentation, but because the wrong party prepared it.
This article clarifies who the FSVP Importer is, who it is not, and why misidentification creates immediate regulatory exposure. For many readers, this is the first moment of realizing they may have assigned responsibility to the wrong entity—and how quickly the FDA will expect them to fix it.
What the FSVP Importer Actually Is
Under FDA’s FSMA framework, the FSVP Importer is the person in the United States who is the owner or consignee of food at the time of entry into the United States – basically, the person who has a financial interest in the food at the time of entry and is therefore responsible for verifying the safety of the foreign supplier and the products they ship. This is not a ceremonial title. It determines who must:
- Develop, maintain, and implement an FSVP
- Conduct supplier verification activities
- Maintain records that satisfy FDA review
In practical terms, the FSVP Importer is the U.S. party that owns or has agreed to purchase the food when it crosses the border. But because many transactions involve brokers, distributors, private-label owners, and contract manufacturers, companies often misassign the role.
If your organization makes any purchasing decisions, controls product specifications, or conducts supplier oversight, the FDA will likely assume you are the FSVP Importer—and will expect records that align with that role.
When uncertainty remains, importers should review the FDA’s foundational expectations and compare them against their own responsibilities using resources such as FSVP checklist essentials.
Who the FSVP Importer Is Not
Many businesses mistakenly assume that the FSVP Importer is automatically one of the following. It is not.
Not the Importer of Record
The Importer of Record (IOR) is a U.S. Customs and Border Protection (CBP) designation used for tariff and duty purposes. The IOR ensures goods are entered correctly, not that suppliers are verified. FDA has made clear that IOR and FSVP Importer identities frequently diverge.
Not the U.S. Agent
The U.S. Agent supports FDA communication for registered food facilities. This is an administrative point of contact—not a food safety verifier. A U.S. Agent does not perform hazard analyses, evaluate supplier performance, or maintain an FSVP.
Not Automatically the Broker or Freight Forwarder
These parties facilitate logistics. Unless contractually given purchasing authority or verification responsibilities, the FDA does not view them as the responsible importer.
Misunderstanding these distinctions routinely results in a mismatch between what the FDA expects to see during an inspection and what the company has prepared. When the wrong entity assumes responsibility, gaps typically appear immediately in hazard analyses, supplier evaluations, and import entry documentation—gaps FDA investigators recognize instantly.
Why Correct Identification Matters More Than Ever
FDA’s FSVP inspections have increased in frequency and depth. The FDA is expanding its use of unannounced inspections at foreign manufacturing facilities, indicating a more aggressive stance on FSVP compliance, especially for smaller and mid-sized importers. The agency is redirecting enforcement toward the U.S. party with meaningful control over the supply chain. If you are that party, FDA will expect:
- Determining and documenting hazard analyses aligned with foreign supplier activities
- Evidence of approval, monitoring, corrective actions, and re-evaluation
- Conducting supplier verification activities
- Records that demonstrate oversight, not just supplier paperwork
Companies surprised by an FDA request often discover that the individual listed as the FSVP Importer at entry has no records—because they never realized they were responsible. That error triggers immediate scrutiny.
How Confusion Between Roles Creates Compliance Gaps
Companies often structure import operations around commercial convenience rather than regulatory designation. For example:
- A broker arranges purchasing but does not maintain safety documentation
- A distributor negotiates pricing but does not evaluate supplier controls
- A private-label owner controls specifications but assigns FSVP responsibility elsewhere
These mismatches create predictable weaknesses in an FSVP—often first exposed when the FDA requests a hazard analysis that the listed importer cannot provide. The agency will not look to who was most involved in logistics; it will look to who had the authority and financial interest to make safety decisions.
The more complex the supply chain, the more essential it becomes to map responsibilities. When buyers realize that proper identification is foundational to every other FSVP duty, they often revisit related requirements using resources such as PCQI’s role in supplier verification.
How to Confirm Who Should Be Listed on Entry
Clarity emerges by answering three questions:
- Who owns or has agreed to purchase the food at the time of entry?
- Who controls supplier product specifications, safety decisions, or supplier approvals?
- Who maintains or should maintain verification records?
If the same entity appears in all three answers, that party is almost certainly the FSVP Importer. If not, your operation may already be out of alignment with FDA expectations.
Importers often pair this evaluation with a review of regulatory distinctions, especially between supplier-based controls and process controls, using resources like HARPC comparisons for clarity.
When Incorrect Identification Leads to Enforcement
During an FSVP inspection, FDA investigators verify whether the listed FSVP Importer can provide the required records:
- Supplier evaluation and approval
- Hazard analysis performed or reviewed by a qualified individual
- Verification activities and follow-up
If the identified party cannot deliver, the FDA will cite the failure directly. In recent enforcement actions, companies have received Form 483 observations and Warning Letters based solely on misidentification—even when the underlying controls existed elsewhere in the supply chain.
These citations enter the public record, impact supply chain credibility, and may trigger Import Alerts on future shipments.
Your Next Step: Ensure the Right Party Is Trained and Prepared
If your company appears on import entry lines, manages purchasing, or plays any role in supplier oversight, you should assume the FDA may view you as the FSVP Importer. That responsibility becomes significantly more manageable when the personnel involved have formal FSVP training. Given the increase in FSVP inspections, it’s critical to business continuity to insure your personnel have the FSVP training needed to help insure regulatory compliance.
Registrar Corp’s FSVP Training is designed to provide:
- A complete, practical understanding of FSVP requirements
- Guidance for determining the correct FSVP Importer
- Instruction on hazard analyses, supplier verification, and FDA expectations
- Examples of documentation that withstand regulatory scrutiny
Training is one of the fastest ways to correct gaps, clarify responsibilities, and prepare your team for FDA oversight.
If you need clarity, confidence, and operational readiness, explore Registrar Corp’s FSVP Training today.
