Food Facility Registration

DUNS requirement for FDA registration

A DUNS Number (Data Universal Numbering System Number) is a unique 9-digit identifier for businesses, issued by Dun & Bradstreet (D&B). It helps verify a company’s identity and establish a business credit file.

A valid DUNS Number is required for FDA registration. The DUNS number serves as a unique facility identifier (UFI), helping the FDA verify business locations and prevent duplicate or fraudulent entries.

Different types of registrations in FDA:

1. Food Facility Registration

The Food Safety Modernization Act (FSMA) requires domestic and foreign food facilities to provide a valid DUNS number when registering or renewing their registration with the FDA. This includes facilities that manufacture, process, pack, or hold food for consumption in the U.S.

2. Drug Establishment Registration

For domestic and foreign drug establishments, the FDA requires a DUNS number when registering an establishment or when creating a user fee account to make OMUFA, PDUFA & GDUFA payments.

3. Medical Devices Establishment Registration

A DUNS number is typically needed for foreign establishments registering their medical devices with the FDA and for creating user fee account to make MDUFA payments to FDA.

Liberty Management Group Ltd can help look up if a facility has a DUNS number or guide to obtain a new DUNS number along with FDA registration.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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 Biennial Registration Renewal

FDA requires all registered domestic and foreign food and dietary supplement facilities to renew their FDA registration every two years. This applies to all the facilities that manufacture, process, pack, or store food, beverages, or dietary supplements intended for consumption in the USA.

Initial Registration: Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the US must register with FDA.
Registration Renewal: FDA registration must be renewed between October 1 and December 31 of every even-numbered year. Next renewal period is October – December 2024.
Purpose of FDA Registration: FDA registration helps the FDA to regulate food facilities effectively and share important information related to food safety.
Penalties: FDA registrations that are not timely renewed get cancelled and shipments of such facilities are refused admission into US

Biennial renewal of food facility registration with the FDA is important for several reasons:

Up-to-date Information:

The biennial renewal process helps the FDA maintain accurate and up-to-date information about facilities. This includes the address, contact details, and the types of activities conducted at the facility. Accurate data is essential for the FDA to respond quickly in case of a food safety issue.

Food Safety:

The renewal process supports the FDA’s ability to monitor and inspect food facilities to ensure compliance with food safety standards. This is crucial for preventing foodborne illnesses and ensuring that food products entering the US market are safe for consumption.

Compliance with FSMA:

FSMA mandates the registration and regular renewal of food facilities. Failure to renew registration can lead to a facility being considered non-compliant, which may result in legal actions, such as the refusal of food shipments, or being prohibited from distributing food in the US.

Efficient Communication:

Up-to-date registration information helps ensure that the FDA can communicate efficiently with facilities in case of emergencies, such as recalls, outbreaks, or other food safety concerns. Efficient communication is key to mitigating risks and protecting public health.

Preventing Market Disruptions:

Timely renewal helps prevent disruptions in the supply chain. If a facility fails to renew, it may face legal or logistical hurdles that may prevent its products from entering the US market, causing potential losses and supply issues.

Liberty management Group Ltd. can help companies with FDA Registration and biennial registration renewal.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

What information is required in the FDA registration of a food facility?

As per 21 CFR 1.232, the following information is required for US and non-US food facility registrations:

Facility name, address, phone number and email address
DUNS number
Preferred mailing address, phone number & email address, if different from facility
Parent company name, address, phone number & email address (if the facility is a subsidiary of the parent company)
Facility Emergency contact name, phone number & email address
All alternate names the facility uses
US Agent name, address, phone number & email address
Name, address, phone number & email address of the owner, operator, or agent in charge
Applicable food product categories of any food manufactured, processed, packed, or stored at the facility
The types of activity at the facility for each food product category
A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, phone number & email address, the individual who authorized submission of the registration.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us