Preparing FDA food facility registration documents manually requires navigating complex regulatory requirements, gathering information across multiple departments, and ensuring precise compliance with federal food safety laws. Attorneys and compliance professionals spend hours cross-referencing regulations, formatting documents correctly, and verifying that all mandatory fields meet FDA specifications.
Food facility registration under 21 CFR Part 1 requires extensive documentation, precise regulatory language, and careful attention to FDA requirements. Manual preparation is time-consuming, error-prone, and requires deep knowledge of Bioterrorism Act compliance, product categorization codes, and biennial renewal obligations.
CaseMark automates the entire FDA food facility registration process, generating compliant documentation that meets all Federal Food, Drug, and Cosmetic Act requirements. Our AI ensures accurate facility information, proper US agent designation, complete product categorization, and legally sound certification statements ready for FURLS submission.
This workflow is applicable across multiple practice areas and use cases
Food importers must register facilities with FDA before importing food products into the United States, making this workflow essential for international trade compliance.
The workflow directly addresses FDA registration requirements under the Bioterrorism Act, which is mandatory for foreign facilities exporting food to the U.S., and the target personas explicitly include international trade lawyers handling food imports.
New food manufacturing, processing, or distribution companies must complete FDA facility registration as part of their initial regulatory compliance setup before commencing operations.
FDA registration is a mandatory regulatory requirement for food businesses, making this workflow a critical component of the corporate formation process for any entity in the food industry.
During M&A due diligence and post-acquisition integration, acquiring companies need to verify FDA registration compliance and update facility registrations for newly acquired food manufacturing operations.
Food facility acquisitions require immediate attention to FDA registration transfers and updates, and this workflow streamlines the compliance documentation needed during transaction closing and integration phases.
Corporate counsel must maintain current FDA registrations and update facility information when there are changes in ownership, management, or operations as part of ongoing compliance governance.
Maintaining accurate FDA registrations is an ongoing corporate governance obligation, and the workflow's ability to handle multiple facility registrations supports companies with complex operational structures.
Under 21 CFR Part 1, Subpart H, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA. Exemptions exist for farms, retail food establishments, restaurants, and facilities regulated exclusively by USDA. CaseMark helps determine if your facility requires registration and generates appropriate documentation.
A US agent is a required designee for all foreign food facilities who serves as the communication liaison between FDA and the facility. The agent must be physically located in the United States, available during business hours, and authorized to represent the facility for FDA communications and inspection scheduling. CaseMark generates compliant US agent designation sections with all required information.
FDA food facility registration must be renewed biennially during the period from October 1 through December 31 of each even-numbered year. Facilities must also update their registration within 60 calendar days of any change to required information. CaseMark includes proper renewal language and can help track your renewal obligations.
Providing false information on FDA food facility registration can result in serious consequences including administrative detention of food articles, civil monetary penalties, and potential criminal prosecution. The registration includes a certification under penalty of law that all information is true and accurate. CaseMark helps ensure accuracy by systematically collecting and organizing all required information according to FDA specifications.
Most facilities must submit registration electronically through the FDA Unified Registration and Listing System (FURLS) or FDA Industry Systems. Paper submission is only available for facilities that qualify for specific exemptions. Upon successful submission, you'll receive a registration number that must be retained and provided upon FDA request. CaseMark prepares your documentation for electronic submission with complete filing instructions.