Next Upcoming Seminar: Food Labeling Compliance Seminar – April 3-4, 2017

Specializing in FDA Regulatory Matters

Foreign Food Facility Requirements

The FDA is increasing the requirements of foreign food facilities that export food products into the United States. Whether the company is a processor, manufacturer, packer/repacker or holder of food, the Food Safety Modernization Act (FSMA) has enacted requirements of all foreign food facilities verify the safety of food similar to those requirements of domestic companies.

Foreign Food Facility Registration:

Like domestic food facilities that manufacturer, process, package of hold foods Foreign Food Facilities must also register with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.   This registration must be renewed every other year, and the FDA may suspend that registration if it determines that that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. In addition, foreign food facilities must have a US Agent located in this country to serve as a communication link with FDA and them and to oversee their facility registrations.

  • EAS Consulting Group provides a US Agent and origin Food Facility registration assistance service  and can serve as a conduit for communications between FDA and the foreign facility.

Foreign Food Facility Inspections:

FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for food safety and to identify any potential problems before the products enter the U.S. marketplace. FSMA mandates that FDA increase the number of foreign food inspections. It also authorizes FDA to charge for any follow-up inspections that result from FDA’s initial inspection.

  • EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.