Category: Food Regulations

FEI – FDA Establishment Identifier

An FEI is an FDA system generated unique number used to identify a firm, establishment, or facility involved in manufacturing, packing and distribution of FDA-regulated products. The FEI helps the FDA track inspections, facility registrations, and other regulatory activities.

FEI is different from DUNS or EIN.

FEI for Drugs

  • Both US and foreign drug manufacturing or processing facility must register with the FDA and is assigned an FEI after registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Medical Devices

  • Manufacturers, contract manufacturers, foreign exporters, initial importers, relabelers, repackagers must register with the FDA and are assigned an FEI upon registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Food

  • The FEI helps the FDA with communication, inspection planning, and tracking facility-related activities during food safety investigations.
  • The FEI is distinct from the food facility registration number, which is an 11-digit FDA-assigned number assigned after registration.

FEI for Cosmetics 

  • The FEI is the required facility registration number used by the FDA to identify cosmetic product facilities in its database.
  • Obtaining an FEI is the first step toward registering a cosmetic facility with the FDA. You must have an FEI before submitting a facility registration.
  • The FEI links the facility registration to product listing submissions, which must include the FEI of each facility manufacturing or processing the cosmetic products.
  • The FEI number does not expire. Once assigned, the FEI remains valid and does not require renewal.
  • The FEI is different from cosmetic facility registration, which must be renewed biennially to maintain compliance.

Liberty Management Group Ltd can help facilities with FDA Regulations for all above product categories.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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

DIETARY SUPPLEMENTS

FDA registration is not required for dietary supplements. However, facilities involved in the production of dietary supplements must register with the FDA. Key points:

  1. Manufacturers, packers, and distributors of dietary supplements must register their facilities with the FDA. This is part of the Food Facility Registration process, which is required under the Bioterrorism Act of 2002.
  2. The registration helps the FDA monitor the supply chain and trace products if there’s a safety concern.
  3. The registration must be updated if any information in registration changes
  4. The registration must be renewed every even numbered year,
  5. Product registration is not required. Dietary supplement manufacturers do not need to register each product with the FDA before selling it, unlike drugs or medical devices. Instead, it’s the responsibility of the manufacturer to ensure the product is safe and labeled according to FDA guidelines.
  6. If a dietary supplement contains a new dietary ingredient (an ingredient not marketed in the U.S. before 1994), the manufacturer must notify the FDA about the ingredient before it is marketed.

Liberty Management Group Ltd. can help you 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:

  1. Failure to submit Registration correctly – FDA may cancel a registration if they find the information to be inaccurate or duplicate.
  2. 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.
  3. 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.

  1. Initial Registration: Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the US must register with FDA.
  2. 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.
  3. Purpose of FDA Registration: FDA registration helps the FDA to regulate food facilities effectively and share important information related to food safety.
  4. 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

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:

  1. 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.
  2. 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.
  3. Foreign facility – any facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the USA.
  4. Manufacturing/processing – making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients.
  5. 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.
  6. Packaging – placing food into a container that is directly in contact with the food.
  7. 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.
  8. Trade name – other names under which the facility conducts business or is known by.
  9. US Agent – person residing or maintaining a place of business in the USA and who is designated as agent by a foreign facility.
  10. 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.
  11. FDA will consider the US Agent the equivalent of the registrant for purposes of sharing information and communications.
  12. 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

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

What does a US Agent do?

A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.

The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.

Key responsibilities of a US Agent may include:

  1. Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
  2. Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
  3. Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
  4. Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
  5. Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.

The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.

Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.

Namrata

Regulatory Consultant

support@libertymanagement.ushttp://www.fdahelp.us

Low Acid Canned Foods & Acidified Foods

The US FDA regulates both Low Acid Canned Foods (LACF) and Acidified Foods (AF).

  1. Low-Acid Canned Foods (LACF):

LACF are low in acid content which provides a conducive environment for the harmful bacteria to grow. FDA regulated LACF products under regulation 21 cfr Part 113.

Manufacturers & processors of LACF are required to register their facility with FDA as a Food Canning Establishment & submit the scheduled process filing for each LACF product. Scheduled process filing provides details of steps in production, time taken, temperatures and other parameters that are necessary to ensure the product’s safety.

  1. Acidified Foods (AF):

Low Acid foods to which acids or acid foods are added to bring the pH level to 4.6 or less are called Acidified foods. Acidified foods are regulated by FDA under 21 cfr Part 114.

Like LACF, AF processors must also register their facility with FDA as Food Canning Establishment & file scheduled process filing for each AF product.

Scheduled process filing for acidified foods include details on the type and amount of acid added, processing times and temperatures.

FDA conducts regular inspections of LACF and AF facilities to ensure regulations are complied with.

Liberty Management Group Ltd. can help you with compliance with FDA requirements for LACF & AF products.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA’s Food Facility Registration Regulation

Domestic and foreign facilities that manufacture, process, pack, or hold food intended for human or animal consumption in the US must register with FDA.

WHY It’s Required: To help FDA to determine the location and source of a potential or actual bioterrorism incident or an outbreak of food-borne illness and allow FDA to notify quickly facilities that may be affected.

WHICH Facilities Must Register: Domestic and foreign food manufacturers, processors, packers, and storage facilities that handle food for consumption in the US.

WHAT is Food:

Some Examples of Foods that Require Facility Registration:

  • Dietary supplements
  • Infant formula
  • Beverages
  • Fruits and vegetables
  • Seafood
  • Dairy products
  • Eggs
  • Bakery goods
  • Chocolate
  • Food for animals

WHEN Facilities Must Register: Before your facility begins to manufacture, process, pack, or hold food for consumption in the United States.

WHO May Register: The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

WHAT is US Agent: Foreign facilities must designate a US Agent, who lives or maintains a place of business in the US and is physically present in the US, for purposes of communication between the facility and FDA.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us