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U.S. FDA Conducted Inspections in 48 Foreign Countries in FY 2014

According to a January 2015 Food Safety Report published by the United States Government Accountability Office (GAO), the U.S. Food and Drug Administration (FDA) conducted inspections in 48 foreign countries in fiscal year (FY) 2014, with China, Japan, and India subject to the most.

FDA told the GAO that foreign inspections are an important part of the Food Safety Modernization Act (FSMA) for several reasons:

  1. They provide accountability for the inspected firms
  2. They provide an incentive for foreign firms to comply with U.S. import requirements
  3. They provide FDA with knowledge regarding food safety practices in foreign countries

FDA has foreign offices in China, Europe, India, Latin America, and in the Asia-Pacific.  Foreign office staff members include some locally employed individuals.  FDA told the GAO that local staff members are beneficial because they “speak the local language and help foreign office staff better understand local regulations.” Local staff members sometimes accompany FDA investigators on inspections.  They help with translation and, in cases where the local staff members are knowledgeable on FDA regulations, may even help with the inspection.

Foreign food facilities that manufacture, process, pack, or store food intended for consumption in the USA are required to register with FDA, designate a U.S. Agent for FDA communications, and consent to FDA inspection. Under FSMA, FDA can refuse U.S. entry for food products from a foreign facility that denies FDA access for an inspection.

FDA investigators are meticulous when conducting inspections.  FDA will inspect everything from the employees’ cleanliness and wardrobe to the method that contents are stored within the facility.  If FDA finds compliance issues during an inspection, the agency may decide to return at a later date to ensure the problems have been resolved. Under FSMA, FDA may charge $305 an hour for foreign reinspections, including the time used to prepare for the inspection and to travel to and from the facility.

Food safety regulations can vary greatly between countries, so it’s prudent to obtain guidance from a firm with expertise in U.S. regulations.  Registrar Corp is a U.S. FDA compliance firm that helps food facilities comply with FDA regulations.  We offer a Mock Inspection Service through which we will send a food safety specialist trained in FDA inspections to a facility to help it prepare.  For facilities that designate Registrar Corp as their U.S. Agent, the Mock Inspection Service is free of charge, other than travel and lodging expenses, when FDA set a date for inspection.

To learn more about U.S. FDA inspections or Registrar Corp’s Mock Inspection and U.S. Agent service, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/LiveHelp.