USA FDA Registration (Food & Medical Devices)

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:

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.

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.

Mock FDA Inspection

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.

Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements:

Following Current Good Manufacturing Practices (CGMPs) help to ensure the safety of food. CGMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food.

In 1969, FDA established CGMPs in the Code of Federal Regulations (CFR) (21 CFR Part 110). In September 2015, the agency modernized the CGMPs and established them in new Part 117 (21 CFR Part 117), along with new requirements for hazard analysis and risk-based preventive controls which where were issued as part of the implementation of the FDA Food Safety Modernization Act (FSMA).

In addition to the CGMPs in Part 117, FDA has issued CGMPs specific to certain types of food.

CGMPs in CFR 21 Part 117

In 21 CFR Part 117, FDA established a CGMP regulation as part of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” rule.

Part 117 establishes requirements for CGMPs and for hazard analysis and risk-based preventive controls for human food (PCHF) and related requirements.

Generally, domestic and foreign food facilities that are required to register with FDA by Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must comply with the requirements for risk-based preventive controls in Part 117 (unless an exemption applies). The modernized CGMPs generally apply to establishments that manufacture, process, pack, or hold food and apply to some activities that are exempt from the preventive controls requirements, such as juice and seafood processing.

Additional CGMPs for Certain Types of Food

Dietary Supplements – 21 CFR Part 111
For additional information, see Dietary Supplements Guidance Documents & Regulatory Information.

Infant Formula – 21 CFR Part 106
For additional information, see Infant Formula Guidance Documents & Regulatory Information.

Low-acid Canned Foods – 21 CFR Part 113
Acidified Foods – 21 CFR Part 114
For additional information, see Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information.

Bottled Water – 21 CFR Part 129
For additional information, see Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information.

Related Resources

Food Defect Levels Handbook
Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard. These “Food Defect Action Levels” listed in this booklet are set on this premise–that they pose no inherent hazard to health.

Filth and Extraneous Materials Program
The filth and extraneous materials program at the FDA supports the agency’s mission by ensuring manufacturers comply with the Federal Food, Drug, and Cosmetic Act and by preventing adulterated foods from reaching consumers.

Historical Background

In 2004, FDA initiated an effort to modernize its CGMP regulations (21 CFR Part 110). The agency hosted three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning CGMPs as well as other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate foodborne hazards that may occur during food production, processing, or storage.

Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements | FDA

FDA REGISTERED - 03/2018