Foreign Facility Registration & US Agent
Non-U.S. food facilities must register with the FDA and designate a U.S. Agent for FDA communications. The U.S. Agent serves as a liaison between your company and the FDA. The U.S. FDA communicates through the U.S. Agent to schedule inspections and to alert you of other FDA matters.
REGISTER-FDA REGISTRATION SERVICE INCLUDES:
- Preparation, and submittal, and receipt of your FDA Food Facility Registration.
- Electronic Certificate of Registration. Companies often need to verify their U.S. FDA food facility registration to suppliers, customers, and importers. The FDA does not issue or publish certificates of food facility registration. Register-FDA’s Certificate of Registration provides documentation for your business partners. Hard-copy certificates can be purchased and mailed to you for USD 95.
REGISTER-FDA U.S. AGENT SERVICE INCLUDES ASSISTANCE WITH THE FOLLOWING FOR 1 YEAR:
- FDA CONTACT: Register-FDA serves as the communication link between FDA and your foreign facility, so that FDA can contact us for routine matters and when an emergency occurs. This means that we are accessible to FDA 24 hours a day, 7 days a week.
- INSPECTION NOTIFICATION: Register-FDA will assist you when you are notified of an FDA inspection and help with communication between your company and the FDA.
- CUSTOMS CLEARANCE: Register-FDA Corp will communicate with your customs broker and freight forwarder on your behalf to provide information about your FDA registration.
- REGISTRATION UPDATES: Any changes to the data on your registration must be submitted to FDA within 60 days. Register-FDA updates your registration at no cost.
- PRIOR NOTICE: A Prior Notice submission must be filed with FDA prior to each shipment of food to the United States. Register-FDA can instruct your customs broker on the Prior Notice filing requirements.