New FDA Strategy Enforces Compliance of Imported Products

David Fiske

Senior Vice President

Lori Hunter

Executive Vice President

February 10, 2020

David Fiske, Senior Vice President
Lori Hunter, Executive Vice President

The increasing globalization of the marketplace has placed new challenges on the U.S. food safety system, prompting the Food Safety Modernization Act (FSMA) to grant the Food and Drug Administration (FDA) new and supplementary oversight and enforcement authority.

These changes, meant to ensure that product safety standards are being met, come in the form of the Foreign Supplier Verification Program (FSVP), which places the burden of food safety on U.S. importers and authorizes the FDA inspection of, and enforcement authority over, foreign facilities.

What the New Strategy Document Means

This year, the FDA is taking additional steps to ensure compliance with the FSVP, including reinspecting importers that have had previous inspection deficiencies and by acting immediately when FSVP deficiencies are found that present an imminent health risk to the public. This dovetails with the FSMA’s recent focus on high-risk foods and emphasis on more stringent record-keeping requirements.

The strategy document that describes how the FDA is integrating the new import oversight tools with existing tools is part of a comprehensive methodology to better ensure the safety of imported food. According to the FDA, the strategy is guided by four primary goals:

  • To ensure that food offered for import meets U.S. food safety requirements.
  • That the FDA border surveillance is successful in preventing the entry of any unsafe foods.
  • To respond to unsafe imported food as rapidly as possible.
  • To ensure that the food import program is effective and efficient.

Preparing Your Clients for the FSMA’s New Regulatory Strategy

All import operations with manufacturing, processing and growing exposures need to ensure compliance with the FSMA’s new requirements, as it is the importer’s responsibility to assess the risks of imported food and verify that the risks are controlled. To enforce the new strategy, the FDA is conducting on-site inspections and issuing observation reports (known as “483s”) at foreign facilities; inspecting and testing at ports of entry, and refusing entry or issuing alerts if applicable; and when necessary, suspending facility registrations.

Your clients can be better prepared for this new regulatory landscape by:

  • Staying updated on changes and knowing what to expect during an inspection.
  • Conducting a mock inspection to identify any critical issues that the FDA is looking for and being prepared to address any noncompliance issues in advance.
  • Working with an outside consultant who can help clients identify issues and ways to best correct them.
  • Participating in the Voluntary Qualified Importer Program to help reduce the likelihood of inspection and testing at the border, along with an expedited review of said tests for the importation of food products.

At Worldwide Facilities, we understand how critical it is for businesses to stay informed on FDA issues and to be prepared. To learn how our industry experts can help your clients with the right product recall coverage, please contact David Fiske at 312-465-5305 or, or Lori Hunter at 213-236-4585 or

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