U.S. importer received FDA warning letter to implement Foreign Supplier Verification Program (FSVP) Regulation

An importer in Southern California is on notice from the FDA for failing to take required steps under the “Foreign Supplier Verification Program” (FSVP) to assure that the smoked salmon and mackerel it brings into the U.S. have been produced in accordance with U.S. food safety regulations.

Staff from the U.S. Food and Drug Administration (FDA) inspected the Van Nuys, CA, location of B&I Overseas Trading Inc. on March 21 and discovered the “significant violation,” according to an April 26 warning letter made public in recent days by the FDA.

“… you do not have or have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation,” according to the letter sent to CEO Donata Inda by Steven E. Porter Jr., FDA’s Los Angeles district director.

Foods “prepared, packed, or held” under conditions that are in violation of the Seafood HACCP (Hazard Analysis and Critical Control Point) are considered adulterated and not fit for sale.

“… you failed to provide adequate product specifications and an affirmative step for the following products: Salmon Cold Smoked Fillet Bit (and) Mackerel Cold Smoked Head Off,” according to the warning letter.

“We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products, … including placing them on detention without physical examination, seize your product(s) and/or enjoin your firm from further violating the Act.”

Food companies are given 15 working days to respond to FDA warning letters. As of June 11 the agency had not posted a closeout notice regarding B&I Overseas Trading

The “Foreign Supplier Verification Program” (FSVP) Rule of the U.S. Food Safety Modernization Act (FSMA), requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a signicant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.


• Who is covered by the rule?

  • For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. See Am I Subject to FSVP? (PDF: 69KB) for more information.
  • There are exemptions discussed below.
  • • 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.•  Importers are responsible for actions that include (and are explained further below):•  Determining known or reasonably foreseeable hazards with each food•  Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

    •  Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

    •  Conducting supplier verification activities • Conducting corrective actions

    •  Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate veri cation activities before being imported.

  • An importer can rely on another entity to conduct the hazard analysis, so long as the importer reviews and assesses the relevant documentation.


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