The FDA has issued a Final Rule amending its regulations for registration of foreign and domestic food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. The rule updates FDA’s registration regulations and improves the utility of the food facility registration database in order to enhance FDA’s capabilities with respect to responding to food related emergencies, and in addition to provide FDA with information that it can use to focus and better utilize its limited inspection resources.
The Rule requires the email address of the contact person or US agents for a foreign facility. It requires an assurance FDA will be permitted to inspect the facility in accordance with the FD&C Act and that registrations must be renewed every two years.
Retail food establishments which primarily sell food products directly to consumers are not covered by the Rule.
Take away: Domestic and foreign food facilities must be sure that their facilities are properly registered with FDA and that their processes otherwise comply with the relevant regulations.