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Assessment of FDA Reinspection and Recall User Fees

The Food Safety Modernization Act (FSMA), signed into law January 4, 2011, created sweeping reforms for the FDA. One of the major reforms involves the user fees to help cover FDA costs. According to the new law, the FDA is authorized to collect user fees to cover 100 percent of their costs for reinspections of domestic and foreign facilities; and food and feed recall activities beginning fiscal year (FY) 2012 and for each year afterwards. The FDA has released an assessment of these fees on September 30, 2011 and are outlined below.

Beginning FY 2012, the FDA will begin to charge reinspection fees. Reinspection, according to the FDA, is defined as one or more inspections conducted by FDA where non-compliance related to food safety has been found where they will determine if the compliance issue has been resolved. If a primary inspection resulted in compliance issues, the FDA will issue an Official Action Indicated (OAI) and will be verified upon reinspection that the issues from the OAI are resolved. The fees for reinspection are $224 per hour for US facilities and $325 per hour on foreign facilities. The fees will be based on direct hours spent on reinspection such as physical surveillance, compliance reinspection, preparation and arrangement for reinspection, travel to and from the facility, preparation of reports, analyzing samples, inspection of labels, and any other action required as specified by OAI the document.

The FDA has also noted that they will assess a fee for non-compliance with a recall order. Non-compliance can include not initiating a recall as ordered by the FDA, not conducting a recall in a manner specified by the FDA, or not providing the requested information regarding the recall to the FDA. The fee will be paid by the party responsible of the domestic facility or the importer that does not comply with a recall order. In all, the party that receives the FDA recall order will be responsible for paying the fees. The fees will be based on the number of direct hours spent taking action. This may include conducting audit checks, reviewing periodic status reports, analyzing those reports and audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The fee rate will be the same as reinspection fees, $224 per hour for domestic facilities and $325 per hour for foreign facilities.

Registrar Corp will continue to post new developments as they are issued. If you have further questions regarding an upcoming inspection, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates