Facilities that handle food or medical products must register with the Food and Drug Administration (FDA) before December 31 to avoid severe penalties.

This rule applies to facilities — domestic and foreign — that import or export such items into or out of the United States. Failure to comply may result in civil or criminal litigation as well as prohibition from import/export activities.

Any facility that participates in the following must submit, renew, update, or cancel registration with the FDA each even-number year:

  • Food Manufacturing
  • Food Processing
  • Food Packing
  • Food Storage
  • Ingredient Storage
  • Pet Food Storage
  • Dietary Supplement Storage

Annual registration is required for any facility that produces or distributes medical equipment intended for the U.S. market. The following domestic and foreign facility types are included in this mandate:

  • Contract Manufacturers
  • Specification Developers
  • Relabelers/Repackers
  • Initial Importers
  • Foreign Exporters

These rules came into effect after the establishment of the Food Safety Modernization Act.

Secure Assistance with FDA Facility Registration 

The clock is ticking to ensure that your medical or food facility remains compliant with FDA registration requirements. Should you need assistance in this process, contact Scarbrough Consulting. Logistics compliance experts are ready to lend a hand.