UPDATE 03/02/2017
FDA’s Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates are out for FY 2017. The domestic reinspection rate was not changed from the 2016 rate. Surprisingly, the foreign reinspection rate, which has been increasing over time since 2013, has decreased by approximately 9.5% from 2016. The new rates, below, went into effect on October 1, 2016 (excluding travel costs):
- Domestic reinspections: $221/hr
- Foreign reinspections: $285/hr
Original Post 09/12/2014
FDA’s Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates are out for FY 2015, and they are higher than ever. The new rates, below, go into effect on October 1, 2014 (excluding travel costs):
- Domestic reinspections: $217/hr
- Foreign reinspections: $305/hr
Domestic food facilities, and U.S. Agents for foreign food facilities, should be aware that FDA’s user fees will be imposed any time FDA must “reinspect” compliance of a facility which was previously inspected and FDA found food safety violations. The reinspection (and its fees) could range from traveling to and physically reinspecting a facility or requesting and reviewing submitted documents. Importers, however, are still subject only to the recall reinspection fee – FDA is still not assessing reinspection fees for imported product.
FDA’s published calculations for determining these fees brought an interesting detail to light: FDA stated that its domestic reinspections average 28 hours (3.5 days), and its foreign reinspections average three weeks. Thus, not only are the rates for foreign reinspections significantly higher, but these reinspections can last four or five times longer.
Though FDA has stated that small businesses’ burden in these fees will be smaller, the agency has not published any guidance detailing what the difference will be. Even if the cost for small businesses is half the regular rate, there’s still no guarantee that the reinspections will be short – or successful! Reinspections are conducted to ensure that corrections are “to FDA’s satisfaction.”
Lesson: Be ready for the first (free) inspection because the second one could really cost you. And get help if you need it.
