On June 3, FDA issued a revised Compliance Policy Guide Regarding Food Facility Registration for Human and Animal Food, which provides guidance for FDA staff on food facility registration requirements, as updated by the Food Safety Modernization Act ("FSMA"). FSMA amended the food facility registration requirements initially established by the Bioterrorism Act of 2002 to require additional registration information, biennial renewal, and assurance that FDA will be permitted to inspect the facility at certain times. FSMA also authorizes FDA to suspend registrations if FDA determines a food facility manufactured, processed, or otherwise handled a food with a reasonable probability of causing harm, and the facility was the cause of the reasonable probability or had reason to know about it. The publication largely reiterates FDA's Guidance for Industry: What You Need to Know About Registration of Food Facilities, which lays out FDA's authority to inspect a facility or suspend a facility's registration.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.