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FSMA & FSVP Compliance Consulting

The Food Safety Modernization Act (FSMA) is the most significant reform of US food safety law in 70 years. LMG helps food importers and manufacturers understand and comply with FSMA — including the Foreign Supplier Verification Program (FSVP), Preventive Controls, and FDA food facility registration.

FSMA 2011FSVP RuleAll Food ImportersSince 2009
6,000+
FSMA-regulated food facilities in the USA
200+
countries from which the US imports food
2011
Year FSMA was signed into law by President Obama
7
major FSMA rules (Preventive Controls, FSVP, Produce Safety, and more)
21 CFR
§ 1.500–1.514 — the FSVP regulatory code

What is FSMA?

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, is the most sweeping reform of US food safety legislation in over 70 years. It fundamentally shifts the focus of US food regulation from responding to foodborne illness outbreaks to preventing them before they occur.

FSMA applies to both domestic food facilities and foreign establishments that export food to the United States. All food facilities subject to FSMA must be registered with FDA — and all US importers of food must comply with the Foreign Supplier Verification Program (FSVP).

FSMA gives FDA mandatory recall authority, the ability to suspend facility registration, enhanced inspection access, and expanded import safety tools including FSVP and third-party accredited certification.

Key Point

FSMA does not eliminate the requirement for FDA food facility registration — it strengthens it. All food facilities must remain registered and in good standing to export to the United States.

What is FSVP?

The Foreign Supplier Verification Program (FSVP) regulation (21 CFR Part 1, Subpart L) is one of the seven major FSMA rules. It requires US importers of food to verify that their foreign suppliers produce food in a manner that meets applicable US food safety standards.

FSVP is the responsibility of the US importer — not the foreign supplier. The US importer must conduct a hazard analysis, evaluate and approve each foreign supplier, perform ongoing supplier verification activities, and maintain records for FDA inspection.

FSVP applies to importers of food for both human and animal consumption. Certain exemptions exist for very small importers, food subject to other FSMA rules with equivalent requirements, and food from countries with recognized comparable food safety systems.


LMG assists both US importers (with FSVP program development) and foreign suppliers (with FDA registration and documentation support) to achieve full FSMA compliance.

The Seven Major FSMA Rules

FSMA established seven major rules that collectively cover the entire food supply chain — from farm to import.
FSMA Rule Regulation Who It Applies To
Preventive Controls for Human Food21 CFR Part 117Food facilities that manufacture, process, pack, or hold human food
Preventive Controls for Animal Food21 CFR Part 507Facilities manufacturing animal food
Produce Safety Rule21 CFR Part 112Farms growing produce for human consumption
FSVP — Foreign Supplier Verification Program21 CFR Part 1 Subpart LUS importers of food for humans or animals
Accredited Third-Party Certification21 CFR Part 1 Subpart MVoluntary program for third-party auditors
Sanitary Transportation of Human & Animal Food21 CFR Part 1 Subpart OCarriers and shippers of human and animal food
Intentional Adulteration (Food Defense)21 CFR Part 121Food facilities registered under FD&C Act

FSVP — Step-by-Step Requirements

US importers must complete these seven activities to maintain a compliant FSVP program. LMG assists with every step.

Determine if FSVP Applies

Identify whether you are the US importer (owner or consignee) and whether the food/supplier is subject to FSVP or qualifies for an exemption.

Conduct a Hazard Analysis

Identify known or reasonably foreseeable hazards for the food — biological, chemical, physical, and radiological — and determine which are significant (requiring control measures).

Evaluate Your Foreign Supplier

Evaluate the foreign supplier’s performance and the risk posed by the food. Review the supplier’s food safety practices, history of compliance, and applicable food safety regulations.

Approve the Foreign Supplier

Formally approve the foreign supplier before importing food. Document the approval decision based on the hazard analysis and supplier evaluation.

Perform Supplier Verification

Conduct appropriate verification activities — on-site auditing (required for high-risk hazards), lot-by-lot testing, review of the supplier’s food safety records, or other procedures. Frequency depends on risk level.

Maintain FSVP Records

Keep all FSVP records for 2 years (some for 3). Records must be available to FDA upon request. This includes the hazard analysis, supplier evaluations, verification activities, and corrective actions.

Review and Update Annually

Review your FSVP at least every 3 years, or whenever there is a change in the food, supplier, or information about the food safety risk — whichever comes first.

Who is the FSVP “Importer”?

Under FSVP, the “importer” is the US owner or consignee of the food at the time of entry into the United States — or, if the food is not owned or consigned by a US person at entry, the US agent or representative of the foreign owner or consignee.

Common misconception: The foreign supplier is NOT the FSVP importer. The US company receiving the food import is legally responsible for FSVP compliance.

FSVP Exemptions

Some importers and food categories are exempt from full FSVP — or have modified requirements:

  • Very small importers (annual sales below $1M combined with supplier, adjusted for inflation)
  • Food subject to juice HACCP or seafood HACCP regulations — provided importer verifies supplier compliance with those rules
  • Dietary supplements and dietary supplement components — subject to modified FSVP requirements
  • Alcoholic beverages — certain exemptions apply
  • Food imported for personal consumption (not for sale)
  • Food from countries with a recognized food safety system (currently Canada and New Zealand with modified requirements)
Even if you qualify for a full FSVP exemption, you may still have modified FSVP obligations. LMG can assess your specific situation and determine your exact compliance obligations.

LMG FSMA & FSVP Consulting Services

LMG provides end-to-end FSMA and FSVP compliance support — from initial assessment through program development, supplier verification, and FDA inspection readiness.

FSVP Program Development

LMG develops a complete FSVP program for your company — written procedures, supplier approval process, hazard analysis templates, and verification activity protocols tailored to your supply chain.

Qualified Individual Guidance

FSVP must be performed by a Qualified Individual within your company. LMG provides the regulatory guidance, templates, and technical support your QI needs to meet all FSVP requirements accurately.

Foreign Supplier Audits

LMG assists with foreign supplier audit planning, audit questionnaire development, and review of third-party audit reports for FSVP compliance — covering both scheduled and for-cause audits.

Food Safety Plan (FSP) Preparation

LMG prepares complete written Food Safety Plans under the FSMA Preventive Controls rule — hazard analysis, preventive controls, monitoring procedures, corrective actions, and recall plan.

FDA Food Facility Registration

All food facilities subject to FSMA must register with FDA. LMG handles the complete registration process including DUNS/UFI number, US FDA Agent designation, and biennial renewal.

FSVP Records & Documentation

LMG helps design and maintain FSVP documentation systems — supplier evaluation records, verification activities, corrective action logs, and audit records ready for FDA inspection.

FSMA & FSVP — Frequently Asked Questions

Common questions about the Food Safety Modernization Act and the Foreign Supplier Verification Program.
The Food Safety Modernization Act (FSMA), signed into law in January 2011, is the most sweeping reform of US food safety laws in over 70 years. It shifts the focus from responding to foodborne illness outbreaks to preventing them. FSMA gives FDA broad authority to regulate how food is grown, harvested, and processed.
FSVP (Foreign Supplier Verification Program) is an FSMA regulation that requires US importers of food to verify that their foreign suppliers are producing food in a manner that meets applicable US food safety standards. Importers must perform supplier verification activities and keep records.
US importers of food for humans or animals must comply with FSVP — with limited exemptions for very small importers, certain low-risk foods, and foods subject to other FSMA rules (e.g., juice and seafood HACCP). An “importer” is the US owner or consignee of the food at the time of entry, or the US agent of the foreign owner.
The US importer is legally responsible for FSVP compliance. The foreign supplier must provide documentation and cooperate with the importer’s verification activities, but the legal obligation rests with the US importer.
FSVP activities must be performed or overseen by a Qualified Individual (QI) — a person within your company who has the education, training, or experience to carry out FSVP activities. The QI does not require a specific certification, but must be able to demonstrate competency. LMG supports your designated QI with regulatory guidance, templates, and technical review throughout the FSVP process.
Required activities include: hazard analysis of the food, evaluation of the foreign supplier’s performance and food safety practices, approval of foreign suppliers before use, and ongoing supplier verification (e.g., annual on-site audits, lot-by-lot testing, or review of food safety records — depending on risk level).
FSVP applies to food imported from all countries. Some modified requirements apply for food from countries with food safety systems recognized as comparable to the US (currently New Zealand). Canada has a recognized food safety system under a separate FDA-Canada arrangement.
FSVP records must be kept for 2 years (or 3 years for some records). Required records include the hazard analysis, supplier evaluation, supplier verification activities, and any corrective actions taken.
The Preventive Controls for Human Food rule (21 CFR Part 117) requires food facilities to have a written Food Safety Plan that includes a hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification activities, and a recall plan.
Yes. LMG provides FSMA consulting services including FSVP program development, support for your company’s Qualified Individual, supplier verification documentation, Food Safety Plan preparation, foreign supplier audit assistance, and FDA food facility registration. Contact LMG for a personalised FSMA/FSVP compliance assessment.

Need FSMA or FSVP Consulting?

LMG provides FSVP program development, Food Safety Plans, supplier verification support, and FDA food facility registration for importers and food manufacturers worldwide.

Contact LMG for FSMA Help Food Registration Form