The Federal Food, Drug, and Cosmetic Act (FD&C Act) makes the U.S. Food and Drug Administration (FDA) responsible for ensuring the safety of the food that enters the U.S. The U.S. FDA also has the responsibility of performing inspections of foreign food processing facilities that produce food that is to be consumed by humans or animals in the U.S. With these inspections, the FDA hopes to identify and resolve any food safety problems with products that are to be shipped to the U.S. prior to their arrival in a U.S. port of entry. Also with the inspections, the FDA will define the compliance status of the foreign food processing facility (whether it meets FDA’s regulatory requirements listed in the Code of Federal Regulations and FDA’s food safety standards). Through the inspection, the FDA makes decisions on the food products admissibility when the food product is offered for importation into the U.S. (Source: FDA)
The U.S. FDA provides written notice prior to an inspection of an overseas food facility. The notice is typically sent to the foreign facility’s email address that the facility previously listed in the FDA Food Facility Registration Module (FFRM). The notice usually proposes a date range for the food facility inspection, to be conducted by one or more investigators from the FDA. The purpose of the inspection is to determine whether the facility is operating in accordance with the Food, Drug and Cosmetic Act, regulations set forth in Title 21 of the U.S. Code of Federal Regulations that are applicable to the products produced in the facility, and other laws FDA enforces. Therefore, the inspection should be during normal operating hours when responsible personnel are available to provide FDA with adequate information about the operations and can allow FDA access to processing and production records.
Additionally, with re-inspection fees as part of the new Food Safety Modernization Act, FDA recently added a statement on the notice advising if a facility will be responsible for any costs incurred by FDA related to the inspection.
The notice typically requires a reply from the foreign facility within 5 days, indicating:
– Whether the proposed dates for the food facility inspection are acceptable.
– Contact name, telephone and fax numbers, and email address for a responsible person at the firm.
– Mailing address for the company.
– Address of any additional facilities that manufacture, process, pack or hold food intended for shipment to the U.S.
– Whether an English-speaking staff member or translator will be present during the inspection.
The FDA notice will always provide a “Respond By” date. Failure to reply to the notice before the stated deadline (or to unreasonably deny the inspection) may be interpreted as evidence that the firm is failing to comply with FDA regulations. This failure to respond could potentially result in the facilities’ products being refused entry into the U.S. until FDA is able to verify, through inspection, that the products meet applicable U.S. requirements.
For questions related to U.S. FDA Foreign Food Facility inspections or any U.S. FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.