FDA FSVP

Foreign Suppliers Verification Programs (FSVP)

The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

What is an FSVP?

It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

Who is covered by the rule?

The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry). If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent. The key is that there be a FSVP importer in the United States who takes responsibility for meeting the FSVP requirements.

Who must be in compliance with the FSVP requirements?

U.S. importers subject to FSVP have foreign suppliers that fall into one of three categories:

Foreign suppliers that will not be covered by the PC or produce safety rules;
Foreign suppliers subject to the PC for Human Food rule and are not “small businesses,” “qualified facilities” (certain very small businesses) or subject to the Pasteurized Milk Ordinance; or
Foreign suppliers subject to the current good manufacturing practices (CGMP) requirements in the PC for Animal Food rule, and are not "small businesses" or "qualified facilities"

What evaluation must be done of the risk posed by an imported food and a supplier’s performance?

An importer must evaluate:

The hazard analysis
The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
A foreign supplier's procedures, processes, and practices related to the safety of food
Applicable FDA food safety regulations, and information regarding the foreign supplier’s compliance
The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
Other factors as necessary, including storage and transportation practices

What supplier verification activities must be conducted?

Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.

Why choose MAGNECO?

MAGNECO offers complete assistance to FSVP importers and/or foreign establishments willing to conform with FSVP rule as follows:

Assistance from our qualified individuals to develop an FSVP and to perform FSVP activities
Perform a hazard analysis
Evaluate risks posed by the food and the performance of the foreign supplier
Conduct appropriate supplier verification activities
Take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate)
Reevaluate the food and foreign supplier every three years or sooner

Magneco food exports FSVP Agent — MAGNECO may serve as your FSVP Agent if you are a foreign exporter

Are you FSVP compliant?

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