FDA Registration

Food Facility Registration

BTS-Consultants helps companies across all FDA-regulated industries comply with FDA registration regulations quickly and properly.

BTS-Consultants can help your facility register with FDA and much more. 

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

• Food facilities register with FDA
• FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States 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. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if 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:

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

We Support to get FDA Registration:

• Human Consumption Products (Salt, Spices, Dry Fruits, Sea Food, Rice, Honey etc.)
• Medical Devices (Class 1 & 2)

USA Agent: 

All registered food facilities located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments and assist in organizing food facility inspections.

FDA may choose to conduct a routine inspection of any registered food facility based on a number of factors. BTS-Consultants can dispatch a Food Safety Specialist to help your facility prepare for an FDA inspection. We offer these to our existing clients at a reduced rate.

Information required for registration

• Facility name, full address, phone number;
• D-U-N-S Number;
• The preferred mailing address, if different from that of the facility;
• Parent company name, address, and phone number (if applicable);
• Email address for the contact person of the facility or, in case of a foreign facility, the Name, address, phone number, and email address of the U.S. Agent for the facility;
• An emergency contact phone number and email address;
• Name, full address and phone number of the owner, operator, or agent in charge. In addition, the email address of the owner, operator, or agent in charge is required, unless FDA has granted a waiver under 21 CFR 1.245;
• All trade names the facility uses;
• Applicable food product categories, as listed on the registration form;
• The type of activity conducted at the facility for each food product category identified;
• Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act; and
• Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so.