FSVP

Foreign Supplier Verification Program

FSVP (Foreign Supplier Verification Program)

The Foreign Supplier Verification Program (FSVP) is one of the key regulations under the FDA FSMA, requiring importers of food into the United States to verify that their foreign suppliers are complying with U.S. food safety standards. Implemented in phases since 2017, it now applies to all food importers. The purpose of FSVP is to ensure that imported foods provide the same level of public health protection as food produced in the United States. Importers must conduct hazard analyses for each foreign supplier and imported food, and establish and implement verification activities to manage those hazards.

Scope of FSVP Application

FSVP applies to all importers bringing food into the United States. An 'importer' is defined as the U.S. owner or consignee of the food at the time of entry, or if there is no U.S. owner or consignee, the U.S. agent or representative of the foreign owner or consignee. However, some foods and importers may be subject to modified requirements or exemptions.

Under FSVP, importers must develop, maintain, and follow a program to verify that their foreign suppliers are in compliance with U.S. food safety regulations. This program includes hazard analysis, supplier evaluation and approval, verification activities, corrective actions, and recordkeeping. Importers must establish an FSVP for each food they import and each foreign supplier of that food.

View FSVP Regulations

• 1. Key FSVP Requirements

  Importers must meet the following requirements:
  • Conduct hazard analysis for foods and foreign suppliers
  • Evaluate and approve foreign supplier performance
  • Conduct appropriate supplier verification activities
  • Establish and implement corrective action procedures
  • Create and maintain FSVP records

• 2. FSVP Implementation Process

  < FSVP Implementation Process >

• 3. FSVP Exemptions and Modified Requirements

  • - Importers subject to Seafood HACCP or Juice HACCP regulations
  • - Specific microbiological hazards controlled under LACF regulations
  • - Food for research or evaluation
  • - Food for personal consumption
  • - Alcoholic beverages (under certain conditions)
  • - Food imported for further manufacturing/processing

• < FSVP Preparation >

  FSVP Preparation

  Importers need systematic preparation to comply with FSVP regulations. They must develop and maintain a written FSVP for each imported food and foreign supplier, which must be performed by a Qualified Individual.

  The FSVP program must include the following:

  • Food hazard analysis (biological, chemical, physical hazards)
  • Foreign supplier evaluation (food safety record, compliance history, etc.)
  • Supplier verification activities (onsite audits, sampling and testing, record review, etc.)
  • Corrective action procedures
  • FSVP reassessment (at least every 3 years)
  • Importer identification and recordkeeping

  Importers must keep FSVP records for at least 2 years and be able to provide them to FDA upon request. Additionally, importers must provide their FSVP importer name, email address, and unique facility identifier (UFI) to customs at the time of import.

• < Importance of FSVP >

  Importance of FSVP

  FSVP is a critical regulation ensuring the safety of food imported into the United States. By requiring importers to verify their foreign suppliers' food safety management, it helps prevent food safety incidents from imported foods and protects public health.

  For non-compliance with FSVP, FDA can take actions such as import refusal, warning letters, and import alerts. Civil penalties may be imposed, and criminal prosecution is possible for repeated violations.

  Therefore, foreign suppliers exporting food to the United States must provide necessary information and documentation to U.S. importers to meet FSVP requirements and comply with U.S. food safety regulations. This is essential for entering and maintaining presence in the U.S. market.

• Types of FSVP Verification Activities

  Verification Activity	Description
  Onsite Audits	The most comprehensive verification method that directly evaluates the foreign supplier's facility and food safety systems. Generally required when the hazard is SAHCODHA (Serious Adverse Health Consequences or Death to Humans or Animals)
  Sampling and Testing	Taking food samples to test for microorganisms, chemical contaminants, allergens, etc. Frequency determined by the nature of hazards and supplier history
  Review of Supplier Food Safety Records	Reviewing supplier's food safety procedures, monitoring records, corrective action records, etc. to verify appropriate hazard control
  Other Appropriate Activities	Supplier questionnaires, third-party certification review, government inspection report review, etc. Determined based on hazard and supplier characteristics

• < IGC's Capabilities >

  IGC's Capabilities

  As an FDA FSMA third-party certification body, IGC provides comprehensive services related to FSVP. We support foreign suppliers in complying with U.S. food safety regulations and assist importers in implementing FSVP.

  IGC provides FSVP training, consulting, and supplier audit services, with food safety experts supporting the development and implementation of customer FSVP programs. We also provide PCQI (Preventive Controls Qualified Individual) training to contribute to developing qualified individuals.

  IGC's experts have experience with various food categories and supply chains, providing practical support in all aspects of FSVP including hazard analysis, supplier evaluation, and verification activity planning.

  IGC is committed to helping customers effectively comply with FSVP regulations and successfully operate their business in the U.S. market.