FDA Food Facility Registration and Renewal Support

Applicability, establishment-identity and U.S.-agent review, initial registration, updates and biennial renewal support for domestic or foreign food facilities subject to FDA registration.

Service overview

Facilities that manufacture, process, pack or hold food for consumption in the United States generally must register with FDA before conducting those activities unless a specific exemption applies. Foreign facilities also provide U.S. agent information. Food facility registration is an establishment-level regulatory registration, not FDA certification of a food product, and it is separate from food-contact material compliance.

Applicable products or businesses

• Applicable facilities supplying food, beverages, ingredients, dietary supplements or animal food to the U.S.
• Foreign manufacturing, processing, packing or holding facilities and their U.S. agents
• Businesses requiring initial registration, biennial renewal, update, cancellation or record reconciliation

Target market

• U.S. food market

Regulatory authority

• U.S. FDA food program

Regulations, directives and standards

• Food facility registration provisions of the FD&C Act and FSMA amendments
• Food facility registration rules in 21 CFR Part 1, Subpart H
• FDA biennial renewal, unique facility identifier and U.S. agent requirements

Service scope

• Initial assessment of facility activities and possible exemptions
• Legal name, address, activity and food-category data reconciliation
• U.S. agent and emergency-contact coordination
• Preparation for initial registration, updates, biennial renewal or cancellation

Service process

• Determine whether the facility is in scope and identify its activities
• Reconcile the legal entity, physical address and unique facility identifier
• Confirm the U.S. agent and authorised contacts
• Prepare and submit the appropriate registration in the FDA system
• Retain confirmations and maintain the record through changes and biennial renewal windows

Information required

• Facility legal name, physical/mailing addresses and contacts
• Parent company, trade names and owner/operator/agent-in-charge details
• Food categories and facility activities
• U.S. agent and emergency-contact information
• Existing registration number, FEI/DUNS or FDA system records where available

## Reports, certificates or registration outcomes Completion may create or update the FDA food facility registration record and system confirmation. The record reflects establishment registration only; it does not mean FDA approval of food, labels, formulations or manufacturing quality and does not replace prior notice, labelling, FSMA or product-specific duties.

Factors affecting timing

Timing depends on establishment-identity matching, unique identifier reconciliation, U.S. agent confirmation, system-account readiness and FDA validation feedback. Biennial renewals must be completed within the statutory window.

Common compliance risks

• Inconsistent English names or addresses create duplicate facility records
• U.S. agent information is submitted without confirmation
• The registration number is promoted as FDA product approval
• Changes in activities, address or ownership are not updated

Related services

• FDA food labelling compliance
• FDA prior-notice information
• FDA food-contact compliance
• FEI information review

Information for an initial assessment

Provide the product name, model, intended use, target market, bill of materials and available reports so that the applicable route and evidence gaps can be assessed.