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FDA Re-Inspection Fee Coverage

In response to rising amounts of foreign-produced foods entering the U.S., the Food and Drug Administration now holds businesses and individuals who act as designated U.S. agents of foreign shippers accountable for the safety of the products they bring into the country. The Food Modernization and Safety Act (FSMA) allows FDA to recover the costs of a site re-inspection from facilities whose original inspection turned up significant violations of food safety standards, and when the offending company is located in a foreign country, it is the company’s designated U.S. agent who is handed the bill. To counter this risk, FDA re-inspection fee coverage protects freight forwarders and customs brokers should one of their international customers fail a site inspection at a facility located abroad.

As of 2015, the fee for an FDA site re-inspection is $305 per hour if the site is located in a foreign country. Considering that billable hours for re-inspection include everything from travel time for inspectors to time spent filing documents, the cost of a repeat inspection can amount to a significant unforeseen expense.

In accordance with FDA guidelines, importers should always perform a thorough assessment of the facilities and compliance practices of foreign companies they agree to represent. As an added protection, in the event a foreign partner fails a site inspection, FDA re-inspection fee coverage can mitigate the risk posed to importers by absorbing the fees FDA charges for a second inspection.