Absolutely. All foreign food facilities exporting food products to the U.S. must be registered with the FDA and must also designate a U.S. Agent. The U.S. Agent serves as the FDA's domestic contact for inspections, communications, and emergencies. Without this registration, products cannot legally enter the U.S. market.

FDA food facility registration must be renewed during the official renewal period, which runs from October 1 through December 31 of even-numbered years. Failure to renew on time results in automatic cancellation of the registration, which can immediately disrupt imports and sales.

If your facility is not registered or your registration lapses, the FDA can block shipments at the U.S. border, issue refusal notices, place products on import alert, and potentially pursue enforcement actions. Many businesses experience costly delays and lost inventory due to missing or incorrect registration.

FSVP is a legal requirement for U.S. food importers to verify that their foreign suppliers meet U.S. food safety standards. It involves hazard analysis, supplier verification activities, recordkeeping, and ongoing monitoring. Simply importing food without FSVP compliance can result in FDA citations and shipment detentions.

Any U.S.-based importer bringing food into the United States is responsible for FSVP compliance. This includes Amazon sellers, distributors, wholesalers, and private label brands importing food products from overseas manufacturers.

Yes. The FDA requires every foreign food facility to designate a U.S. Agent. The U.S. Agent acts as the FDA's official domestic contact and must be available to respond to FDA inquiries, inspection scheduling, and emergency communications.

FDA Prior Notice is an electronic notification submitted to the FDA before food shipments arrive in the U.S. It provides details about the product, shipper, manufacturer, and destination. Without proper Prior Notice, shipments can be refused entry or held by U.S. Customs.

No. FDA registration does not equal product approval. It simply means your facility is registered as required by law. The FDA does not approve most food products before sale, but it does enforce compliance through inspections and regulatory oversight.

Yes. Any facility that holds food for consumption in the U.S., including warehouses, fulfillment centers, cold storage locations, and distribution hubs, typically must register with the FDA unless specifically exempt.

Yes. Dietary supplements are regulated as food under FDA law. Facilities that manufacture, package, or hold supplements must register, and imported supplements require FSVP compliance just like other food products.

HACCP (Hazard Analysis and Critical Control Points) is a preventive food safety system designed to identify and control potential hazards. It is mandatory for certain food categories such as seafood and juice and is strongly recommended for most food operations under FSMA regulations.

While it is technically possible, many businesses make mistakes involving facility roles, product categories, owner/operator details, and U.S. Agent information. Errors can cause registration cancellation or shipment delays. Using a professional service ensures accuracy and compliance.

When handled correctly, registration is typically completed within 24 to 48 hours. However, incorrect information or missing details can significantly delay approval or trigger FDA follow-up requests.

All human and animal food products sold or imported into the U.S. fall under FDA jurisdiction. This includes packaged foods, beverages, spices, supplements, pet food, raw ingredients, and processed products.

FSMA (Food Safety Modernization Act) focuses on preventing food safety problems rather than reacting to them. It introduced requirements such as FSVP, preventive controls, supplier verification, and food safety planning for many food operations.

Yes. FDA Registration Assistance provides full FSVP Agent services, including hazard analysis, supplier verification documentation, recordkeeping, and ongoing compliance support.

FDA inspections may review facility conditions, sanitation practices, food safety plans, supplier records, labeling, and compliance documentation. Inspectors may issue observations that must be corrected to avoid enforcement actions.

Yes. While the brand owner may not manufacture the product, the manufacturing or holding facility must be registered. Importers must also comply with FSVP when sourcing from foreign suppliers.

Yes. Import alerts occur when the FDA detains products without physical examination due to compliance concerns. We assist with corrective action plans, documentation, and regulatory strategies to regain compliance.

The FDA itself does not charge a government fee for food facility registration. However, professional compliance services ensure filings are accurate and meet all regulatory requirements.

If you import any food into the U.S., you almost always require FSVP compliance. There are limited exemptions, but most importers are legally responsible for supplier verification activities and recordkeeping.

Yes. We track renewal deadlines, update facility information, manage FSVP documentation, and provide continuous regulatory support so you remain compliant year after year.

Depending on your operation, this may include facility registration, U.S. Agent designation, FSVP plans, supplier audits, food safety plans, labeling documentation, and Prior Notice records.

FDA Registration Assistance ensures accurate filings, no compliance gaps, faster processing, reduced risk of FDA enforcement, and expert regulatory support. Mistakes can cost thousands in shipment delays, refusals, and penalties — professional compliance protects your business and keeps your supply chain moving.

A Food Canning Establishment (FCE) registration is required by the FDA for any facility that manufactures, processes, or packs thermally processed low-acid foods (LACF) or acidified foods (AF) packaged in hermetically sealed containers. This includes producers of canned vegetables, soups, sauces, and shelf-stable beverages. Facilities must also submit a Scheduled Process Identification (SID) for each product formulation. We handle both FCE registration and SID submissions to keep your operation fully compliant.

Our service fee is $429 for us to carry out the registration and $429 for the U.S. Agent fee, for a total of $858. The FDA itself charges no government fee for food facility registration. This all-inclusive pricing covers your complete registration submission through the FURLS portal, designation of a U.S. Agent physically located in the United States (required for foreign facilities), confirmation of your FFR number, and biennial renewal reminders.

A DUNS Number is a unique 9-digit identifier issued by Dun & Bradstreet that the FDA uses as the Unique Facility Identifier (UFI) on each food facility registration. It is required for new registrations and renewals. If you do not have one, we can assist in obtaining your DUNS Number as part of the registration process.

Under 21 CFR 1.234, any change to facility information — including address, ownership, U.S. Agent, contact details, or product categories — must be reported to the FDA within 60 calendar days of the change. Failing to update within 60 days puts your registration out of compliance and can trigger cancellation or import refusals.

FDA Registration Assistance serves food businesses in over 135 countries worldwide. With 15+ years of experience and 1,000+ clients registered, we handle the unique compliance challenges facing foreign manufacturers, exporters, and importers shipping food to the U.S. market.