Dietary supplements, including dietary ingredients are legally foods and subject to the same food facility registration requirements. Like domestic facilities that manufacturer, process, package of hold dietary supplements, Foreign Facilities must also register with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This registration must be renewed every other year, and the FDA may suspend that registration if it determines that that supplement manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. In addition, foreign facilities must have a US Agent located in this country to serve as a communication link with FDA and them and to oversee their facility registrations.
- EAS Consulting Group provides a US Agent and origin Facility registration assistance service and can serve as a conduit for communications between FDA and the foreign facility.
Foreign Dietary Supplement Facility Inspections:
FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace. FSMA mandates that FDA increase the number of foreign inspections. It also authorizes FDA to charge for any follow-up inspections that result from FDA’s initial inspection.
EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.