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FSMA to Increase the Likelihood of FDA Inspections of Foreign Food Facilities

The United States Food and Drug Administration (FDA) recently released statistics as to the number of foreign food facility inspections performed by FDA in Fiscal Year 2011:

Time Number of Inspections
October 2010 39
November 2010 37
December 2010 44
January 2011 35
February 2011 35
March 2011 51
April 2011 28
May 2011 51
June 2011 19
July 2011 46
August 2011 21
September 2011 32
Total 438

The Food Safety Modernization Act (FSMA) was signed into law January 4, 2011 and will be implemented over the next few years. In the 1-year period following the date of enactment of FSMA, FDA shall perform not fewer than 600 foreign facilities inspections. 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

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

The hourly rates will be $325/hr for time outside the United States and $224/hr for associated activities performed in the United States relating to the reinspection. Fees will be charged 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. 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.