Food Registration – FDA Support

Does FDA cancel Food Facility Registrations?

Food Facility Registration is an FDA requirement for all domestic and foreign facilities that manufacture, process, pack, or hold human or animal food for consumption in the USA. US FDA can cancel or revoke a food facility registration under certain circumstances. If an FDA registered facility fails to meet the FDA’s requirements, the FDA has the authority to suspend or cancel that registration.

Common scenarios in which the FDA might cancel or suspend food facility registration:

Failure to submit Registration correctly – FDA may cancel a registration if they find the information to be inaccurate or duplicate.
Failure to renew Registration – Food facilities are required to renew their registration every two years. If a facility fails to do so, the FDA may cancel the registration. In such case, facilities must re-register prior to exporting.
Failure to Comply with FDA Regulations – If a facility fails to comply with FDA regulations, such as food safety requirements or FSMA, the FDA may revoke or suspend its registration. Non-compliance could include violations like:

Failing to meet sanitation standards.
Inadequate hazard analysis and lack of proper food safety procedures.
Failure to comply with the FSVP for foreign facilities.
Failure to Respond to an FDA Inspection – If a facility undergoes an FDA inspection and the inspection reveals significant violations or non-compliance, the FDA can revoke or suspend the registration.
Product Recalls or Serious Safety Issues – FDA may cancel a food facility’s registration if serious safety issues arise, such as the facility being involved in recalls, foodborne illness outbreaks, or repeated non-compliance with GMP regulations.
Failure to Cooperate with FDA Investigations – If the FDA is conducting an investigation and the facility does not cooperate (e.g., not providing records or access to information), the FDA may suspend or cancel the facility’s registration.

Consequences of a Canceled or Suspended Food Facility Registration

If the FDA cancels or suspends a food facility’s registration, it has serious implications for the business:

Inability to Import Food: A canceled or suspended registration means the facility cannot import food into the US until the registration is reinstated.
Business Interruption: The facility will be unable to legally manufacture, process, pack, or hold food for U.S. consumption, which can significantly disrupt business operations.
Legal and Financial Consequences: In some cases, a facility may face penalties, fines, or other legal consequences if its registration is canceled due to violations or non-compliance.

How to Avoid Cancellation of Food Facility Registration

Timely renewal of your registration (every two years).
Compliance with all applicable FDA regulations, including food safety practices, labeling requirements, and FSMA regulations.
Proper documentation and recordkeeping

Liberty Management Group Ltd. can help you with FDA registration, re-registration, and renewals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA Food Facility Registration Definitions

FDA requires US and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the USA to register with FDA.

Important definitions:

Facility – any establishment, structure, or structures under one ownership at one general physical location that manufactures, processes, packs, or holds food for consumption in the USA.
Domestic facility – any facility located in the USA, the District of Columbia, or the Commonwealth of Puerto Rico that manufactures, processes, packs, or holds food for consumption in the USA.
Foreign facility – any facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the USA.
Manufacturing/processing – making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.
Holding – storage of food and includes activities performed incidental to storage of a food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
Packaging – placing food into a container that is directly in contact with the food.
Packing – placing food into a container other than packaging the food and includes re-packing and activities performed incidental to packing or re-packing a food.
Trade name – other names under which the facility conducts business or is known by.
US Agent – person residing or maintaining a place of business in the USA and who is designated as agent by a foreign facility.
The US Agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications. The US Agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.
FDA will consider the US Agent the equivalent of the registrant for purposes of sharing information and communications.
Registrant – the owner, operator, or agent in charge of a facility that manufactures, processes, packs, or holds food for consumption in the USA.

Liberty Management Group Ltd. can help you with FDA registration & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Trade Name vs Brand Name

A trade name is also known as DBA “Doing Business As”. If a company runs its business under more names than one, the names other than the legal registered name are called its trade names or DBAs.

On the other hand, a brand name is a name used by a manufacturer or organization for a product or service.

Every food facility marketing its products in US, whether domestic or foreign, must register with FDA all its addresses where it processes, manufactures, packs or stores its food products. An FDA registration is for a specific business address not for individual products. A company may select any number of product categories on a single registration of a business address but for each of its business locations it must have a separate registration.

Each facility is identified by its legal registered business name. This is the name on government forms and applications. If a company conducts business under different names, it does not need to complete registrations for each trade name separately. All alternate names under which it conducts business may be listed in one registration under section Trade Names. Brand names are not required to be included in a registration.

An example of above:

Company X Inc has one location where it manufactures and packs its food products and another location where it labels and stores these products before sending shipments to US. Company X Inc also runs its business under name EX. In this case, Company X Inc will have 2 registrations under its legal name – one for each location and will list its trade name EX as a Trade Name in both the registrations. In both registrations, it can list all its products and more, if it has any.

Once a company is registered, its clients may seek a certificate acknowledging that it is FDA registered and that the registration is valid.

For every registration completed by LMG, we issue a certificate of registration to our clients. All the trade names a facility uses to conduct its business may be listed on the certificate.

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance registrations, labels, and many more FDA regulations.

Namrata Gusain

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on April 05, 2019

Why is Prior Notice important?

Prior Notice is a notification issued to FDA prior to the importation of an article of food for human or animal consumption into USA. This includes 50 US states, District of Columbia, Puerto Rico only. The US territories are not covered under this definition.

Food that is imported with inadequate Prior Notice is subject to refusal and detention at the port of entry.

For Prior Notice, food includes all foods for human or animal consumption, irrespective of intended use.

Prior Notices are considered inadequate:

When there is either no prior notice submitted, or
The information submitted in prior notice is inaccurate, or
The prior notice is not submitted in accordance with required timeframes.

The requirement for prior notice is not based on the requirement of FDA registration. FDA registration is required for facilities that are engaged in manufacturing, processing, packing or holding of food for consumption in USA. Prior Notice is required for articles of food imported into US.

There are two online systems available that may be used to file Prior Notices namely., FDA’s PNSI and CBP’s ABI/ACS. For a prior notice submitted via CBP’s ABI/ACS, you may not submit prior notice more than 30 calendar days before the anticipated date of arrival. For a prior notice submitted via the FDA’s PNSI, you may not submit prior notice more than 15 calendar days before the anticipated date of arrival.

The requirement of Prior Notice does not apply to:

Food for personal use that accompanies the individual.
Home made food sent as personal gift to another individual in US.
Food that is imported & then exported and doesn’t not leave the port of arrival.
Meat and Poultry food products regulated exclusively by USDA.
Food brought in diplomatic bags.

Any person with knowledge of the required information may submit prior notice for an article of food being imported.

Timeframes for submitting Prior Notice:

For foods arriving by international mail –

For foods arriving by road, 2 hours before arrival;
For foods arriving by rail or by air, 4 hours before arrival;
For foods arriving by water, 8 hours before arrival

For foods arriving by Express Couriers like FEDEX – before the food is sent

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance with Prior Notice, FDA registration and other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 06, 2019