There is a regulation sitting in the Federal Register that most US coffee importers either don't know about, misunderstand, or assume someone else is handling.

It's called the Foreign Supplier Verification Program — FSVP — and since its enforcement phase began, the FDA has been conducting surprise audits of green coffee importers specifically to check whether it's being followed.

The penalty for non-compliance isn't a slap on the wrist. It can mean detained shipments, import alerts that flag every future container you bring in, FDA Form 483 citations published on a public database, and civil monetary penalties that can reach tens of thousands of dollars per violation.

If you are importing coffee into the United States — whether you're a roastery sourcing direct from Ethiopia, a private label brand bringing in Vietnamese Robusta, a café chain managing its own supply chain, or a distributor handling green coffee for multiple clients — this regulation applies to you. Not to your freight forwarder. Not to your customs broker. To you.

InGain LLC's founder Davit Ghazaryan is FSPCA-certified — the FDA's recognized credential for FSVP compliance. We provide FSVP guidance to every US coffee importer we work with, because we've seen firsthand what happens to those who don't have it sorted.

The Legal Foundation: FSMA and Why It Changed Everything

In 2011, President Obama signed the Food Safety Modernization Act (FSMA) — the most significant overhaul of US food safety law since 1938. FSMA fundamentally shifted the FDA's approach from responding to foodborne illness outbreaks to preventing them.

The Foreign Supplier Verification Program, codified under 21 CFR Part 1, Subpart L, is one of FSMA's seven major rules. It was finalized in 2015 and has been in full enforcement since 2018. Coffee — including green, unroasted beans — is regulated as a food under the Federal Food, Drug, and Cosmetic Act. Every green coffee shipment you import falls squarely under FSVP.

What Exactly Is FSVP? The Five Core Requirements

FSVP is not a form you fill out once. It is an ongoing compliance program — a documented system that you maintain, update, and have ready to present to the FDA upon request.

1. Hazard Analysis

You must identify and evaluate known and reasonably foreseeable hazards associated with your imported food — in this case, green coffee. Your analysis must cover:

• Biological hazards: Salmonella and other pathogens, mould, and the mycotoxin Ochratoxin A (OTA), which can accumulate in improperly dried or stored green coffee.
• Chemical hazards: Pesticide residues, heavy metals (cadmium, lead), and polycyclic aromatic hydrocarbons (PAHs).
• Physical hazards: Foreign material — stones, metal fragments, and other debris — particularly in commodity-grade lots processed without optical sorting.

Your hazard analysis must be documented in writing, specific to each food and each supplier. A single generic document covering "all coffee from all suppliers" does not satisfy the requirement.

2. Supplier Evaluation

Based on your hazard analysis, you must evaluate whether your foreign supplier is producing coffee in a manner that adequately controls the identified hazards. This evaluation must consider the supplier's compliance history with US food safety regulations, the risk posed by the food, the supplier's food safety practices, and any relevant certifications (ISO 22000, FSSC 22000, SQF, etc.). You must re-evaluate your supplier at minimum once every three years.

3. Supplier Verification Activities

You must conduct ongoing verification activities to confirm the supplier is maintaining the food safety standards you've documented. The FDA identifies four acceptable types:

• Onsite audits — A physical visit to the supplier's facility to review practices, records, and controls. For most FSVP importers of green coffee, this is the primary verification method. Annually is a reasonable baseline.
• Sampling and testing — Laboratory testing for OTA, pesticide residues, moisture content, and potentially heavy metals.
• Review of supplier records — Reviewing the supplier's own food safety records. Appropriate as a supplemental activity but generally insufficient as the sole method.
• Review of food safety certifications — If your supplier holds a recognized third-party certification, reviewing it can constitute a verification activity.

4. Corrective Actions

If a verification activity reveals a problem — failed audit, out-of-spec lab result, or an FDA warning about your supplier — you must take prompt corrective action. This can include stopping imports from that supplier pending investigation, requiring corrections, increasing verification intensity, or terminating the supplier relationship. All corrective actions must be documented.

5. FSVP Records

Every element of your FSVP program must be documented and records maintained for a minimum of two years from the date of the activity. Records must be written in English and available to the FDA upon request within 24 hours. During an unannounced audit, FDA investigators will ask for these records on the spot.

The DUNS Number Requirement — The Detail Most Importers Miss

Since July 24, 2022, FSVP importers must provide a DUNS (Data Universal Numbering System) number for their foreign supplier in the CBP entry filing. If your supplier does not have a DUNS number, the FDA can flag the shipment.

• Before placing an order with a new supplier, obtain their DUNS number.
• Confirm the DUNS number is active and matches the supplier's legal entity name and address.
• Provide this number to your customs broker or IOR for inclusion in the CBP entry filing.

At InGain LLC, we maintain DUNS records for all active suppliers and include them in every shipment entry as standard.

The FSVP Importer vs. The Importer of Record — A Critical Distinction

This is the most consequential misunderstanding in green coffee import compliance, and it costs importers money every year.

The Importer of Record (IOR) is the entity legally responsible for the physical and administrative entry of goods into the US through CBP — ISF filing, entry documentation, customs bonds, and payment of any duties or fees. For a full breakdown of the CBP entry process, see our Complete FDA & CBP Import Guide →

The FSVP importer is the US owner or consignee of the imported food at the time of entry — the brand, the roastery, the distributor, or the buyer. This is almost always you — not the logistics provider.

These are not the same entity, and the FSVP importer responsibility cannot be transferred to the IOR. The FDA will not accept "my broker handled it" as a defense during an audit. They will ask for your hazard analysis. If you don't have one, you are not compliant.

What Non-Compliance Actually Looks Like: The Consequences

• FDA Form 483 — Notice of Inspectional Observations: Issued when an FDA investigator identifies conditions or practices that may constitute violations. Form 483s are published in the FDA's public database — visible to your customers, retailers, marketplace partners, and competitors.
• Warning Letters: Formal FDA communication constituting official notice of legal jeopardy, publicly posted on FDA.gov. Requires a written response and corrective action plan within 15 business days.
• Import Alerts: A directive to CBP instructing them to detain your shipments without physical examination. Every subsequent shipment can be detained and refused entry until the alert is lifted — a process that can shut down your supply chain for months.
• Civil Monetary Penalties: The FDA has authority to pursue penalties up to $10,000 per violation for individuals, with each instance of non-compliance potentially constituting a separate violation.

Who Needs FSVP — And Common Reasons Importers Think They're Exempt

The FSVP rule applies to any US entity that imports food for humans or animals into the United States. Most coffee importers do not qualify for any exemptions.

Who is definitely covered:

• US roasteries importing green coffee directly from origin
• Private label coffee brands importing green or roasted coffee
• Distributors who import coffee and resell to US buyers
• Café chains managing their own direct import supply chains
• Marketplace sellers who import coffee under their own name

If you are buying green coffee domestically from a US importer (such as InGain LLC operating as a domestic seller), the FSVP obligation rests with the original importer — not you as the domestic buyer. This is one practical reason why working with InGain LLC as your domestic supplier can simplify your compliance posture in early-stage operations.

What a Compliant FSVP Program Looks Like in Practice

For a US roastery or private label brand importing green coffee from two to four suppliers, a fully compliant FSVP program typically consists of:

• A written FSVP procedure document covering your overall program structure, hazard analysis methodology, supplier evaluation criteria, verification activities and frequency, and corrective action procedures.
• Individual supplier files for each foreign supplier — containing the hazard analysis, supplier evaluation, FDA registration number, DUNS number, verification records, and corrective action documentation.
• An annual review calendar tracking when each supplier is due for verification activities, re-evaluations, and records retention limits.
• A designated FSVP responsible individual within your organization who maintains records and can represent the program to an FDA auditor.
• Laboratory testing agreements for OTA, pesticide residues, and moisture content with a third-party FSMA-accredited lab.

How InGain LLC Supports Your FSVP Compliance

We built our operation around making import compliance manageable for roasteries, private label brands, and distributors who don't have a full-time compliance department.

Our FSPCA-certified founder Davit Ghazaryan personally provides FSVP guidance to every customer we work with:

• We walk you through the hazard analysis process for each origin and supplier before your first shipment.
• All InGain LLC suppliers hold active FDA facility registrations and DUNS numbers — verified before any partnership begins.
• We provide supplier food safety documentation to support your verification activities.
• We include DUNS numbers in every CBP entry filing as standard practice.
• We flag any changes in supplier status or compliance posture that could affect your FSVP program.

FSVP Readiness: Your Self-Assessment Checklist

Run through this now. If any answer is "no" or "I don't know," you have a gap to close before your next shipment.

• ☐ I have a written hazard analysis for every green coffee supplier I currently import from
• ☐ My hazard analysis addresses biological, chemical, and physical hazards specific to green coffee
• ☐ I have conducted a formal supplier evaluation for each active supplier in the past three years
• ☐ I have completed at least one verification activity for each active supplier in the past 12 months
• ☐ I maintain records of all FSVP activities for a minimum of two years
• ☐ My supplier's DUNS number appears in my CBP entry filings
• ☐ My supplier holds an active FDA facility registration
• ☐ I have a designated person responsible for FSVP within my organization
• ☐ I have a corrective action procedure documented
• ☐ I understand the distinction between my IOR obligations and my FSVP importer obligations

Start With Compliance, Not After It

The coffee importers who get caught off-guard by FDA audits are not bad actors. Most of them are small to mid-size operations that simply didn't know FSVP applied to them, or assumed their logistics partner was handling it.

The regulation doesn't care about intent. It cares about documentation.

Get your FSVP program in order before your next shipment — not after a Form 483 lands on your desk.

Talk to InGain LLC About FSVP Guidance →

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Related Reading

• • How to Import Coffee to the USA: Complete FDA & CBP Guide →
    
    
    
    
    
  • How to Start a Private Label Coffee Brand in 2026 →

InGain LLC is a Wyoming-registered coffee importer and Importer of Record (IOR) with FSPCA-certified FSVP guidance capability. This article is for informational purposes only and does not constitute legal advice.