Category: US FDA Registration

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.

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MoCRA

MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It expands the FDA’s authority over cosmetics, introduces mandatory registration, safety, and reporting requirements, and aims to strengthen public health protections for cosmetic products.

Key aspects of MoCRA include:

  • Facility Registration: Cosmetic manufacturers and processors must register their facilities with the FDA and update such registration biennially.
  • Product Listing: A responsible person must list every marketed product (including ingredients) and renew such listing annually.
  • Good Manufacturing Practices (GMP): The law requires compliance to GMPs, which sets standards for product safety and quality in manufacturing.
  • Adverse event reporting: Manufacturers must track and report any serious adverse health incidents linked to their products.
  • Safety substantiation: Companies must do all safety testing and keep evidence.
  • Labeling requirements: Product labels must be FDA compliant.

Certain Small businesses may be exempt from some MoCRA requirements, although exemptions do not apply to products intended for use in the eyes, injected, or otherwise specifically regulated under FDA drug regulation.

Liberty Management Group Ltd can help facilities with FDA Registration & product listing and label compliance.

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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.

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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.

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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

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HOW TO FILE A DMF

DMF (Drug Master File) is a confidential & detailed submission to FDA.

There are several steps involved in filing a DMF with the US FDA:

1. Determine the Type of DMF

Identify the type of DMF you need to file (Type II, III, IV, or V).

2. Prepare the DMF Document

  • Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
  • Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
  • Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
  • References and Appendices: Include all relevant references, supporting documents, and appendices.

3. Format of Document

The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.

4. Compile the Submission

  • Ensure all sections are complete and properly formatted.
  • Compile the document into eCTD format.

5. Obtain a Pre-Assigned Number

Request a pre-assigned application number for DMF from the FDA.

6. Submit the DMF

Submit the DMF electronically via the FDA’s ESG portal.

7. Pay the Fee

Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.

8. Acknowledge Receipt

Once submitted, FDA will acknowledge receipt of the DMF.

9. Annual Updates and DMF amendments

  • Submit annual updates and amendments as needed.
  • Keep the FDA informed of any changes to the DMF’s content or contact information.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

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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.

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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

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Drug Master File

A Drug Master File or (DMF) is a confidential submission to the US FDA that provides detailed information about facilities, processes, or components used in the manufacturing, processing, packaging, and storing of drugs.

The DMF is submitted by a manufacturer, supplier, or developer of an API (active pharmaceutical ingredient), excipient, or packaging material, and it allows them to provide information to the regulatory authority without disclosing the information to their customers or competitors.

A DMF is referenced in a drug application, such as an ANDA or NDA Application, by the applicant who intends to use the information contained in the DMF to support their own application. The regulatory authority can then review the information in the DMF as part of the evaluation of the drug application.

The purpose of a DMF is to provide information to the regulatory authority, without disclosing proprietary information to the public, to support the regulatory review process of a drug product. This allows the regulatory authority to evaluate the quality, safety, and efficacy of the drug product without needing to disclose confidential information to third parties.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  3. Type III: Packaging Material
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  5. Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF original and annual report submissions & US Agent service.

Namrata

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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