FSVP — Foreign Supplier Verification Program

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Section 1 — Importer Information

U.S. importer of record responsible for FSVP compliance

The FSVP importer is the U.S. owner or consignee of the food at the time of U.S. entry, or the U.S. agent or representative of a foreign owner or consignee.

Importer Legal Name *

DBA / Trade Name (if different)

DUNS Number

FDA Facility Reg. Number (if applicable)

EIN / Tax ID (optional)

Street Address *

City *

State *

ZIP Code *

Country

Contact Name *

Contact Title / Role

Contact Email *

Phone *

Fax (optional)

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Section 2 — Foreign Supplier Details

Information about the foreign food facility supplying the product

Supplier / Facility Name *

FDA Foreign Facility Reg. Number (if registered)

DUNS Number (if available)

Country of Supplier *

Supplier Street Address *

City / Province *

Region / State

Postal / ZIP

Supplier Contact Name

Supplier Contact Email

Supplier Phone

Type of Facility *

Applicable Food Safety Regulation in Supplier Country

Additional Notes on Supplier (optional)

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Section 3 — Food Product Details

Description of the food article being imported

Product / Food Article Name *

Brand Name (if applicable)

HTS (Harmonized Tariff) Code *

FDA Product Code (if known)

Country of Origin *

Product Description *

Intended Use / Consumer *

Form of Product

Requires Refrigeration?

Annual Import Volume (approx.)

Existing Supplier Relationship *

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Section 4 — Hazard Analysis & Verification Activities

Identification of known or reasonably foreseeable hazards and verification methods

Per 21 CFR 1.506, the FSVP importer must conduct a hazard analysis to identify and evaluate hazards requiring a control. Indicate all applicable hazards and the verification activities used.

Known or Reasonably Foreseeable Hazards *

Select all that apply:

Biological (e.g. Salmonella, E. coli, Listeria) Chemical (e.g. pesticides, mycotoxins, additives) Physical (e.g. metal, glass, bone fragments) Radiological Allergen cross-contact Economically Motivated Adulteration (EMA) No known hazards requiring control

Hazard Description (describe specific hazards identified)

Supplier Verification Activities Used *

Select all that apply:

Onsite audit of foreign supplier Sampling and testing of food Review of food safety records Third-party audit (accredited CB) Certificate of conformance / CoA Govt. inspection records from supplier country Other (describe below)

Verification Frequency

Other Verification Activities (if selected above)

Corrective Actions Taken (if any non-conformances found)

Date of Most Recent Hazard Analysis *

Date of Most Recent Supplier Verification

Is the Supplier Subject to an FDA Import Alert?

Import Alert Details (if applicable)

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Section 5 — Qualified Individual (QI)

Person responsible for conducting FSVP activities per 21 CFR 1.502

A Qualified Individual must have education, training, or experience (or a combination thereof) necessary to perform the FSVP activities. They are not required to be an employee of the importer.

QI Full Name *

Job Title / Role *

Organization / Employer

Email *

Phone *

Is QI same as importer contact?

QI Qualifications / Credentials *

Select all that apply:

FSVP Importer Training (FDA/AFDO) Preventive Controls Qualified Individual (PCQI) HACCP Certified Food Science / Microbiology Degree Industry Experience (5+ years food safety) Third-party Consultant / Firm Other (describe below)

Certifications / Training Details

Other Credentials (if selected above)

QI Responsibilities for this Product (optional)

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Section 6 — Certification & Submission

Review, sign, and submit your FSVP data collection

FSVP Recordkeeping Requirement: Per 21 CFR 1.510, FSVP importers must maintain records of all FSVP activities for at least 2 years. These records must be made available to FDA upon request. By submitting this form, you authorize Regovant LLC to retain these records on your behalf and to submit them to FDA as part of your FSVP compliance program.

📜 Terms & Conditions

Regovant LLC provides FSVP consulting and data collection services to assist importers in meeting their obligations under 21 CFR Part 1, Subpart L. Submission of this form does not constitute legal advice and does not guarantee FDA compliance. Regovant LLC is not responsible for inaccuracies in the information provided by the submitter. The importer remains solely responsible for FSVP compliance. All data collected will be stored securely and used only for the purpose of regulatory submission and consultation. Regovant LLC may contact you to clarify information or request additional documentation. By checking the agreement box below, you confirm that all information provided is accurate and complete to the best of your knowledge.

I confirm that all information provided is accurate, that I am the FSVP importer of record or an authorized representative, and that I understand my obligations under 21 CFR Part 1, Subpart L.

Printed Name *

Title / Position *

Signature (type full name) *

Date *

Email for Confirmation *

Foreign Supplier Verification Program (FSVP)

Section 1 — Importer Information

Section 2 — Foreign Supplier Details

Section 3 — Food Product Details

Section 4 — Hazard Analysis & Verification Activities

Section 5 — Qualified Individual (QI)

Section 6 — Certification & Submission

FSVP Data Submitted