The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the US register with the U.S. Food and Drug Administration (FDA).
Each physical location must be separately registered, and the registration must include the name and address of the facility, and all trade names under which the registrant conducts business from that facility.
Food Facilities located outside of the United States must have US FDA Agent who acts as the domestic communications representative for that facility. Foreign facilities must provide the US FDA agent information at the time of FDA registration, and must update the FDA registration information if the facility changes the US FDA agent.
Docent Pharma aids in FDA food facility registration and also provides US FDA Agent service for foreign food facilities.
Please note FDA does not issue a registration certificate, nor does the FDA recognize a registration certificate issued by a third party or registration expert or service provider, but the FDA issue a registration number for each registered food facility, FDA registration number does not denote the FDA approval of the facility.
Docent Pharma provides;
- Assistance in Data Universal Number System (DUNS) Request
- US FDA Agent Service for Foreign Food Facilities
- Food Registration and Renewal Assistance
- Assistance in Filing Prior Notice of Imported Foods
- Food Canning Establishment (FCE) Registration & Process Filing (SID Numbers) Assistance
- Dietary Supplement Label Review Assistance