Author: Namrata

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

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/

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

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

Does the FDA approve cosmetic products or companies?

Cosmetics are articles that are intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.

FDA does not approve cosmetic products or companies. Facilities that are engaged in manufacturing, processing & distribution of cosmetic products are required to comply with below FDA requirements under FDA’s MoCRA regulation.

Cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law. It is the responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.

Liberty Management Group LTD  provides assistance with Cosmetic Product Registration, Cosmetic Product Listing, Label Review and other FDA regulations.

Namrata

FDA 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

Key Terms under MoCRA

FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit cosmetic facility registration with FDA.

FDA also requires that for each cosmetic product, the responsible person must submit to FDA a cosmetic product listing.

Key terms under MoCRA:

CONTRACT MANUFACTURER — a facility that manufactures or processes a cosmetic product on behalf of another entity.

COSMETIC PRODUCT– a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

DUNS NUMBER — The Data Universal Numbering System (DUNS) number is a unique nine-digit identification number issued by D&B. The DUNS Number is sites specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a DUNS number.

FACILITY – any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

Excluding:

  • Beauty shops and salons
  • Cosmetic product retailers
  • Hospitals, physicians’ offices, and health care clinics
  • Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer
  • Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services
  • Trade shows and other venues where cosmetic product samples are provided free of charge
  • An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale
  • An establishment that solely performs one or more of the following with respect to cosmetic products:
  • Labeling
  • Relabeling
  • Packaging
  • Repackaging
  • Holding
  • Distributing

FEI – FDA Establishment Identifier – It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA-regulated products. FDA intends to use a facility’s FEI number as the cosmetic product facility’s registration number.

MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT – means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

OPERATOR – a person who has management authority over an establishment.

OWNER – a person who has an ownership interest in an establishment.

RESPONSIBLE PERSON – 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.

SMALL BUSINESSES — means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products:

  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual
  • Cosmetic products that are injected
  • Cosmetic products that are intended for internal use
  • Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

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

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

FDA Clearance vs FDA Registration

FDA Clearance & FDA Registration are two separate processes associated with the US FDA.

FDA clearance is a process specific to medical devices. It is applicable to low or moderate risk devices that are categorized by FDA as Class I or Class II. This process is also called 510(k) clearance.

When a manufacturer intends to market a new medical device, they may submit a 510(k) premarket notification to the FDA. This submission demonstrates that the new device is substantially equivalent to an FDA cleared device. In FDA clearance, FDA evaluates whether the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance. If the FDA determines that the device is substantially equivalent, it is cleared for marketing.

FDA registration is required for for various FDA Regulated products, including medical devices, food, drug and cosmetics. FDA registration is for facilities or establishments that are involved in the manufacturing, processing, packing, or holding of FDA regulated products.

Companies engaged in above activities must register their facilities with the FDA. This includes providing information about the types of products manufactured, processes used, and other relevant details. Registration is a requirement for companies involved in the production and distribution of FDA Regulated products. It helps the FDA keep track of facilities and facilitates inspections to ensure compliance with regulatory standards. Upon successful registration, the facility is assigned an FDA registration number.

Liberty Management Group Ltd. can help you with FDA clearance for medical devices and FDA registration for Drugs, Cosmetic, Medical Devices & Food.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us