Namrata – FDA Support

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

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.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

FDA Prior Notice

Prior Notice refers to a US FDA requirement under which any food imported into the US must be notified to the FDA before it arrives. This helps the FDA protect the food supply from bioterrorism and other threats.

What Products Require Prior Notice?

Food and beverages for humans or animals.
Dietary supplements
Raw agricultural products intended for consumption
Food ingredients and additives

What foods do not require Prior Notice:

Homemade goods for personal use, or non-food items, don’t require prior notice.

What Must Be Included in the Prior Notice?

Identity of the food
Manufacturer FDA Registration
Shipper and country of origin
Estimated arrival date and time
Port of entry and carrier details
US recipient or importer

When Must It Be Submitted?

By land: At least 2 hours before arrival
By air: At least 4 hours before arrival
By sea: At least 8 hours before arrival
By international mail: Before the package is sent

Who can Submit Prior Notice

Anyone with information about the shipment.

What Happens If You Don’t File It?

Shipments may be refused entry, detained, or destroyed
The importer may face penalties or enforcement actions

Liberty Management Group Ltd can help facilities with FDA Registration & prior notice submissions.

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:

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.
The registration helps the FDA monitor the supply chain and trace products if there’s a safety concern.
The registration must be updated if any information in registration changes
The registration must be renewed every even numbered year,
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.
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:

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

Types of FCE-SID Process Filing forms

Low-acid canned food

A low-acid canned food has the following characteristics:

      1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
      2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
      3. Receives a heat treatment for the purpose of achieving commercial sterility.
      4. Normally stored and distributed under non-refrigerated conditions.

Acidified food

An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under nonrefrigerated conditions.

FDA requires manufacturers and processors of low acid canned and acidified food products to submit Food Canning establishment registration using Form 2541 and to submit process filing using Form 2541d, e, f and g.

Form 2541d – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541d is intended for:

Low-acid food products where the growth of microorganisms is controlled through the application of heat to foods.

Form 2541e – Commercial processors who manufacture, process, or pack thermally processed acidified foods packaged in hermetically sealed containers

Form 2541f – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541f is intended for

Low-acid food products where the growth of microorganisms is controlled through the amount of water available for microbiological growth (i.e. “water control” products); and
Low-acid food products where the growth of microorganisms is controlled through multiple physical and/or physicochemical hurdles (i.e. “formulation control” products).

Form 2541g – Commercial processors who manufacture, process, or pack thermally processed low-acid foods packaged in hermetically sealed containers. Form FDA 2541g is intended for:

Low-acid foods where the growth of microorganisms is controlled through the application of heat to foods and where the processing involves use of aseptic processing and packaging

Liberty management Group Ltd. can help companies to file FCE and SID process filings with FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Drug Master Files

A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.

The submission of a DMF can be made by:

API manufacturers
Excipient manufacturers:
Container Closure System manufacturers
Drug Product manufacturers

Types of DMF:

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
Type III: Packaging Material.
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
Type V: FDA Accepted Reference Information

Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.

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

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us