In January 2011, the U.S. Congress passed the Food Safety Modernization Act (FSMA) providing FDA with the new authority to charge reinspection fees. If a primary inspection results in compliance issues related to food safety, FDA may designate the inspection “Official Action Indicated” (OAI). A reinspection may be be conducted to verify that the issues from the OAI are resolved.
On Wednesday August 1, 2012, the U.S. FDA released the FY 2013 reinspection fee rates (effective from October 1, 2012 through September 30, 2013):
- $221/hour if domestic travel is required
- $289/hour if foreign travel is required.
These new fees reflect a decrease in FDA’s previous reinspection fees imposed from October 1, 2011 through September 30, 2012, which were:
- $224/hour if domestic travel is required
- $325/hour if foreign travel is required.
For domestic facilities, the reinspection fee must be paid by the party responsible for the domestic facility. Under FSMA, FDA will send the invoice for a foreign food facility’s reinspection to the U.S. Agent listed in the firm’s food facility registration. Importers who have been designated as U.S. Agent now are responsible for their suppliers’ FDA reinspection fees. In order to avoid the costly reinspection fees, current U.S. Agents may be replaced by a different U.S. Agent such as Registrar Corp.
Due to the new obligations imposed on the U.S. Agents, it is now critical to have a professional U.S. Agent handle FDA communications. Registrar Corp’s nineteen global offices can provide regulatory assistance to exporters. Registrar Corp has a team of multilingual Regulatory Specialists that are available 24/7. As a foreign facility’s U.S. Agent, Registrar Corp can renew a facility’s registration properly, and handle FDA communications professionally. In addition, as part of Registrar Corp’s U.S. Agent service, Registrar Corp will dispatch a food safety expert trained in FDA inspections to the foreign facility to help the manufacturer prepare if a notice of FDA inspection is received after October 1, 2012. This assistance is included at no additional charge other than travel and lodging expenses for Registrar Corp’s U.S. Agent clients.
For more information about the Food Safety Modernization Act (FSMA) or any FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.