Category: Uncategorized

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

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

ISO 9001 Certification

ISO 9001 certification is an internationally recognized standard for quality management systems  developed by the International Organization for Standardization (ISO). It outlines the criteria for establishing, implementing, maintaining, and continually improving an effective quality management system within an organization.

An organization may choose to implement 9001 for its entire operations or for a particular department.

The ISO 9001 standard is based on several quality management principles, including a strong customer focus, the involvement of top management, a process approach, and continual improvement.

Organizations that achieve ISO 9001 certification have demonstrated their ability to consistently provide products and services that meet customer and regulatory requirements. Certification involves an independent assessment by a certification body to ensure that the organization’s quality management system complies with the requirements of the ISO 9001 standard.

ISO 9001 certification is applicable to organizations of all sizes and industries, from manufacturing and service providers to non-profit organizations and government agencies. It can enhance credibility, improve processes, increase customer satisfaction, and provide a competitive advantage in the marketplace.

Liberty Management Group Ltd can help organizations with ISO 9001 consultation, documentation, implementation & certification

Namrata

Regulatory Consultant

support@libertymanagement.us

https://www.libertymanagement.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

Drug Master File (DMF)

A Drug Master File (DMF) is a confidential submission to FDA to provide detailed information about the facilities, processes or articles used to manufacture, process, package or store human drugs.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. It is submitted by a drug manufacturer to provide confidential information about the drug’s quality, safety, and efficacy. The information submitted in a DMF is usually referenced only during the IND, NDA, ANDA or export application. A DMF contains technical information about a drug, including its chemical and physical properties, manufacturing processes, and analytical methods.

DMFs are often submitted by drug manufacturers to support the approval of their drug products. 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

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

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

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

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

MOCRA – Modernization of Cosmetics Regulation Act of 2022

Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:

Manufacturers and processors must register their facilities with the FDA and renew such registration biennially. FDA no longer accepts VCRP registrations so Facilities that were registered under the VCRP program will have to register again under the new system.

A responsible person must list each marketed cosmetic product and ingredients with the FDA and must renew such listing annually.

  • Good Manufacturing Practices (GMP)

Cosmetic manufacturing and processing facilities must comply with GMP standards.

Cosmetic product labels must adhere to new cosmetic labeling requirements.

  • Adverse Event Report

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA. FDA will have access to adverse event reports during an inspection.

  • Product Safety Substantiation

A responsible person is required to ensure and maintain records supporting adequate safety               substantiation for their products.

  • Mandatory Recall

FDA has the authority to order a mandatory recall, if deemed necessary, if the responsible person refuses to do so voluntarily.

A responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Liberty Management Group Ltd. can help you with Facility Registration, Product Listing, Label compliance and other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

Low Acid Canned Food and Acidified Food

Low-acid canned foods are foods with a finished equilibrium pH greater than 4.6 and a
water activity greater than 0.85, excluding tomatoes and tomato products having
a finished equilibrium pH less than 4.7. They are processed at high
temperatures in airtight containers to prevent contamination & growth of
harmful bacteria.

An acidified food is a low-acid food to which acid ingredients are added and which
has a finished equilibrium pH of 4.6 or below and a water activity greater than
0.85. This makes the food more acidic and creates an environment that is
unfavorable for the growth of microorganisms.

Low-acid canned foods & Acidified foods are regulated by the US FDA and
manufacturers and processors must follow strict guidelines for processing and labeling these
products.

Manufacturers and processors of Low-acid canned foods & Acidified foods must register with FDA
as a food facility, submit a Food Canning Establishment Registration &
process filing of such products.

FDA FCE (food canning establishment registration) is a process by which facilities
that engage in the commercial processing and packing of acidified and low-acid
canned foods must register with the US FDA.

Liberty Management Group Ltd. can help you with Food Facility Registration, FCE, label compliance and other FDA regulations.

 

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

 

UFI for FDA Food Facility Registrations

FD&C Act requires all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in US to register with FDA. The FSMA Act amended the food facility registration requirements requiring food facilities to renew the registrations between Oct – Dec every even numbered year and to provide an FDA recognized Unique Facility Identifier (UFI) in their FDA registration. As per the regulation FDA will not confirm a facility’s new registration or renewal until FDA verified the accuracy of the UFI and verified that the facility-specific address associated with UFI matches with the facility’s information in registration.

FDA intends to conduct the verification process for UFI as below:

  1. For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.
  2. For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

In August 2018, FDA recognized Data Universal Numbering System D-U-N-S (DUNS) as an acceptable UFI for the food facility registration regulation. The DUNS number is assigned and managed by Dun & Bradstreet and is available free of charge.

Liberty Management Group Ltd can help you with biennial registration renewal and DUNS update. For assistance, please visit our website.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 07, 2022