U.S. Food and Drug Administration – Food Facility RegistrationFruits

Control Union has extended its services to the food and beverage industry to provide FDA food facility registristration and U.S. Agent services. With its focus on offering a one-stop-shop approach, Control Union seeks to facilitate food and beverage companies in meeting their responsibilities when exporting to the U.S. market.

U.S. Federal Food, Drug, and Cosmetic Act (Law)

Under Section 415 of the FD&C Act (21 U.S.C. 350d), the FDA requires domestic and non U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with FDA.

As of December 31st, 2014, any food facilities who has NOT registered and/or does not have a US agent may be:

  1. unable to export to the U.S. and
  2. their products entering into the US are subject to being detained.


U.S. Food Safety Modernization Act (FSMA Law)

The FDA Food Safety Modernization Act (FSMA), was enacted on January 4, 2011 and later amended in section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. The amendment  under FSMA requires food facilities to register with FDA to renew their registrations every other year. Included is the authority of FDA to suspend the registration of a food facility if the FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

  • Created, caused, or was otherwise responsible for such reasonable probability; or
  • Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.

Who needs to register under this law?

  • Food and Beverages
  • Dietary Supplements
  • Alcohol
  • Drug Products
  • Medical Devices

What can Control Union do for you?

  • Food facility registration
  • Act as U.S. Agent
  • Other services such as food safety certification

Why should you choose Control Union?

  • Presence in more than 60 countries
  • Experts in food safety
  • We can offer integrated services for a One Stop-Shop approach for registration and certification needs

How do I register?

After filling out the registration form, you will receive instructions on how to get started.


More informationU.S. Food Safety Modernization Act (FSMA Law)