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U.S. FDA Food Facility Inspections (Part 2 of 5)

The United States Food and Drug Administration (FDA) will be expected to increase the number of foreign food facility inspections every year for the next five years. The Food Safety Modernization Act (FSMA), signed into law January 2011, has begun to be implemented. FSMA will greatly affect the food and beverage industry imposing new regulations. In addition to new regulations, FSMA denotes an increase in the number of food facility inspections. FSMA states that in the 1-year period following the date of enactment, FDA shall perform not fewer than 600 foreign facilities inspections. Moreover, in each of the 5 years following the 1-year period, FDA shall inspect not fewer than twice the number of foreign facilities inspected during the previous year. By this schedule, FDA is mandated to inspect no fewer than:

Year Foreign Food Facility Inspections
2011 600
2012 1,200
2013 2,400
2014 4,800
2015 9,600
2016 19,200

Furthermore, FSMA mandates that FDA begin charging hourly fees for reinspecting foreign food facilities starting October 1, 2011. FSMA requires these reinspection fees “to be paid by the United States Agent for each foreign facility.” (Federal Register, Vol. 76, No. 147, Page 45823). This means that FDA will send invoices directly to the person or entity designated as U.S. Agent in the foreign facility’s FDA registration (FFRM) and the U.S. Agent shall be obligated to pay the foreign facility’s FDA reinspection fees. (Federal Register, Vol. 76, No. 147, Page 45825).

FSMA sets the hourly rates at $325/hr for time outside the United States and $224/hr for associated activities performed in the United States relating to the reinspection. FDA will charge fees to the U.S. Agent, without limit, for “whatever components” are deemed necessary per inspection “until the facility is in compliance.” (Federal Register, Vol. 76, No. 147, Page 45822).

Current U.S. Agents wishing to avoid this financial obligation should have the foreign facility immediately remove them as its U.S. Agent. However, since foreign facilities are required to identify a U.S. Agent for FDA Registration, they may satisfy this requirement by designating Registrar Corp to replace you as U.S. Agent. Registrar Corp’s global team of regulatory specialists assists companies with FDA compliance. By serving as U.S. Agent for thousands of foreign facilities around the world, Registrar Corp is already organized to manage these risks.

For questions related to U.S. FDA Foreign Food Facility inspections or any U.S. FDA regulation, you can contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.