On October 7, 2011, the FDA opened docket FDA-2011-D-0721 for the Guidance for Industry on Implementation of Fee Provisions of the FDA Food Safety Modernization Act. This means that comments related to facility reinspection and recall order fees that began October 1, 2011 can be submitted to the FDA either electronically or via the mail.
Despite the comment period, the FDA has still noted that any facility reinspection where the first inspection occurred on or after October 1, 2011 can expect to receive an invoice for the inspection fees. Similarly, a recall order issued on or after October 1, 2011 can expect to receive an invoice as well. During an initial inspection, the FDA has noted that they will provide an information sheet outlining the fees for reinspection and describing instances where a facility reinspection fee can be collected. The facility being inspected will be informed during the initial inspection that they could pay a fee for reinspection if their violations are “materially related to a food safety requirement of the FD&C Act.” The FDA is not expected to send out invoices until after January 1, 2012.
For now, the FDA has postponed the Importer Reinspection User Fee. The FDA has noted that they will evaluate these fees and notify the public prior to assessing them. 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 +1-757-224-0177 or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: https://www.registrarcorp.com/fda-updates