Yes — a U.S. Agent is legally required for every foreign food facility, drug establishment, medical device manufacturer, and cosmetic facility registering with the FDA. The U.S. Agent must be a person or company physically located in the United States, available during normal business hours to act as FDA's official point of contact. Without a valid U.S. Agent, your FDA registration cannot be completed. FDA Registration Assistance provides dedicated, responsive U.S. Agent services for companies in all 135+ countries we serve.

FDA registration renewal requirements vary by industry: Food facilities must renew biennially during the October 1 – December 31 window in even-numbered years — missing this deadline automatically cancels your registration. Drug and device establishments must update their registration annually between October 1 and December 31. Cosmetic facilities under MoCRA must renew every two years. Lapsed registrations can trigger import detentions, border holds, and shipment refusals. FDA Registration Assistance tracks all renewal deadlines and manages the process proactively on your behalf.

The Foreign Supplier Verification Program (FSVP) is an FDA-mandated program under FSMA that requires U.S. food importers to verify that their foreign suppliers meet U.S. food safety standards. FSVP applies to virtually every U.S. importer of food — including Amazon FBA sellers, retail chains, distributors, and contract importers — unless a specific exemption applies. Non-compliance with FSVP can result in import refusals, FDA warning letters, and legal liability. FDA Registration Assistance provides full FSVP agent services, hazard analysis documentation, supplier verification records, and ongoing compliance management.

For most facility registrations, FDA processing typically takes 24–48 hours once all required information is correctly submitted. However, incomplete or inaccurate submissions can extend this to days or weeks, delaying your ability to legally import or market products in the U.S. Using a professional registration service like FDA Registration Assistance ensures all information is complete, accurate, and formatted correctly from the start — eliminating back-and-forth with the FDA and guaranteeing the fastest possible turnaround for your registration.

Required documents vary by industry. Food facilities need their facility address, owner/operator details, and product categories. Drug establishments must provide facility information, drug types manufactured, and contact details. Medical device companies need establishment information, device classifications, and 510(k) or exempt product details. Cosmetic facilities require facility address, responsible person contact, and product listing data under MoCRA. FDA Registration Assistance gathers and prepares all required documentation on your behalf — ensuring accurate, rejection-free filings.

No. Selling FDA-regulated products through Amazon, Shopify, eBay, or any other online platform does not waive your FDA registration obligations. If your products are food, drugs, medical devices, or cosmetics entering the U.S. market, registration and compliance requirements apply regardless of your sales channel. Unregistered companies face import alerts, border holds, shipment seizure, FDA warning letters, and potential civil or criminal penalties. Register before you import or sell in the United States — not after you receive a compliance notice.

Resolving an FDA import alert or product detention requires a formal corrective action plan (CAP), supporting compliance documentation, and direct engagement with the FDA's district office. The process varies depending on whether the alert is due to unregistered facility status, labeling violations, adulteration issues, or prior notice failures. FDA Registration Assistance has extensive experience helping companies across all industries get removed from FDA import alerts — including preparing corrective action documentation, updating registrations, and communicating with FDA on your behalf. Contact us immediately if your shipments are being detained.

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in 2022, is the most significant update to U.S. cosmetic regulation in decades. Under MoCRA, all domestic and foreign cosmetic facilities that manufacture or process cosmetics for U.S. sale must register with the FDA and submit product listings. Additionally, a Responsible Person must be designated for each cosmetic product, and facilities must maintain safety records and adverse event reporting systems. MoCRA registration deadlines have already passed — non-compliant cosmetic companies risk import refusals and enforcement. FDA Registration Assistance handles complete MoCRA registration, product listings, and ongoing compliance for cosmetic brands worldwide.