Turnkey US FDA Registration Services & Official U.S. Agent

Under 21 CFR § 1.227, the US Food and Drug Administration (FDA) strictly mandates that foreign facilities located outside the United States designate an official U.S. Agent who physically resides or maintains a place of business in the USA. The U.S. Agent acts as the direct 24/7 communications bridge between the FDA and the foreign facility, including scheduling on-site facility inspections. Virtual offices, PO boxes, or unanswered answering services are explicitly prohibited and will result in immediate registration invalidation. IntBizTH provides an authentic, fully staffed U.S. Agent office in the United States to ensure 100% legal compliance.

US FDA government fees depend entirely on product classification: (1) Food, Beverage & Dietary Supplement Facilities: There is $0 government fee charged by the FDA. However, biennial renewal is mandatory every even-numbered year between October 1 and December 31. (2) Cosmetics (MoCRA): There is $0 FDA government fee for facility registration and product listing. (3) Medical Devices: Annual establishment registration user fees are collected directly by the FDA (approx. $10,000 - $14,000+ USD depending on fiscal year). IntBizTH charges transparent, competitive service fees for preparation, filing, and U.S. Agent representation with zero hidden fees.

A DUNS Number (Data Universal Numbering System) is a unique 9-digit corporate identifier issued by Dun & Bradstreet. The FDA mandates the DUNS number as the primary Unique Facility Identifier (UFI). The business name, physical street address, and spelling in the Dun & Bradstreet database must match the FDA registration application 100% character-for-character. Any discrepancy causes instant automatic system rejection. IntBizTH assists with DUNS verification, profile reconciliation, and expedited issuance before FDA submission.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most comprehensive reform of US cosmetics legislation since 1938. It mandates: (1) Cosmetic Facility Registration for all manufacturing/processing plants, (2) Product Listing for each individual cosmetic formulation and ingredient profile submitted via Cosmetics Direct, (3) Adequate Safety Substantiation dossiers, and (4) A US domestic address/phone contact on product labels for Serious Adverse Event Reporting. IntBizTH handles the entire MoCRA compliance pathway for both contract manufacturers and brand owners.

Prior Notice involves submitting advance electronic shipping data to both the US FDA and U.S. Customs and Border Protection (CBP) prior to arrival at a US port of entry. Minimum timeframes are: 8 hours prior to arrival for maritime vessel, 4 hours for air or rail cargo, and 2 hours for road transport. Shipments arriving without a confirmed Prior Notice confirmation number (PNC) or with mismatched FDA numbers will be refused admission, held at the port of entry at the importer's expense, or subjected to destruction. IntBizTH provides complete Prior Notice filing services for every commercial consignment.

Once an active DUNS Number is available, IntBizTH completes Food Facility or MoCRA Cosmetics registrations within 2 to 3 business days. Upon successful registration, you receive: (1) Your official 11-digit FDA Registration Number, (2) Master access credentials to your official FDA portal account, and (3) An Official Certificate of Registration issued by our U.S. Agent office, widely accepted by US customs brokers, major retailers (Amazon, Walmart, Costco), and international ocean freight carriers.