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FDA Establishment Registration

We are consultants and FDA US Agents supporting worldwide manufactures, distributors simplifying very broad and often frustrating and complicated online registration and listing formalities.

In general, FDA regulates:

The Food and Drug Administration of United States (US FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of Food Supply, Drugs and Biological(s), Medical Devices, Cosmetics, Radiation Equipment’s and Tobaccos by regulating the manufacturing, marketing, and distribution.

Owners or operators of places of business (also called ESTABLISHMENTS or FACILITIES) that Manufacture, Repack, Relabel, Export or Import  products in the aforementioned industries must REGISTER their facilities with the US FDA.The US FDA Registration process varies dependent on the type of product but generally involves an annual or biannual, if commercially available for distribution in the U.S.

1. FDA Establishment Registration of Food Facility

US FDA Food Registration is effective from December 12,2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, also known as “Bioterrorism Act” directs the food regulatory agency of the Department of Health and Human Services, so called Food and Drug Administration (US FDA) to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To comply with the above provisions of the Bioterrorism Act, FDA established following mandatory regulations:

  • All Food Facilities Register with FDA so called “FDA Registration”
  • Prior information on shipments of imported food to FDA so called “Prior Notice”

Owners, Operators, or Agents in charge of Domestic or Foreign Facilities that Manufacture / Process, Pack, or Hold (Warehouse) food for consumption in the U.S. are required to register the facility with the FDA.

US FDA Food Facility Registration.
FDA Food Establishment Registration Fees.
FDA Food Facility Registration Application Form.

2. FDA Establishment Registration of Drug Facility

FDA Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States. Domestic and Foreign establishments that manufacture, repack, or re-label drug products for the purpose of marketing in the United States are required to complete FDA Registration and followed by list all of their commercially marketed drug products.

As per  21 CFR Part 207.21(a) and FD&C act section 510 (c) (d) and (i), FDA Registration must be completed within 5 days of beginning operations. In addition, establishments must renew US FDA Registration annually between October 1st and December 31st of each year.

Type of Drugs are the following:

  • Prescription drugs (both brand-name and generic)
  • Non-Prescription (Over-The-Counter) drugs

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs or in short this covers medicines such as fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens.

Frequently Asked Questions.
US FDA Drug Establishment Registration.
FDA Drug Facility Registration Fees.
FDA Drug Registration Application Form.

3. FDA Establishment Registration of Medical Device Facility

Owners or operators involved in the Manufacturing  and Distribution of medical devices intended for use in the United States including those that are imported for export only, are required to complete annual FDA Registration. This process is also called as FDA Medical Device Establishment Registration.

As per CFR 807 most of the establishments that are required to complete FDA Registration are also required to list the devices

Who all has to complete Medical Device Registration and Listing.

It is important to note that the devices exempted from PMA or 510k clearance are allowed to register with FDA directly.

FDA 510k information.
Medical Device FDA Establishment Registration application form.
Medical Device FDA Registration Fees.

4. FDA Establishment Registration of Cosmetic Facility

As per US FDA Cosmetic Facilities has to complete FDA Registration as per Voluntary Cosmetic Registration Program (VCRP). VCRP is a reporting system for manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

The VCRP applies only to cosmetic products being sold to consumers in the United States.
VCRP is NOT applicable to cosmetic products for professional use only, or used in skin care clinics or cosmetics not for sale and for cosmetics you make in your home to give to your friends.

Useful information

How to achieve FDA Approval?  
FDA never approve any health care product manufacturer. FDA have the authority to inspect facilities to verify that they comply with applicable good manufacturing practice regulations.Read More >>>

How to achieve FDA Certificate?
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their U.S. FDA registrations status and Validity. A Certificate of Registration issued by Our Company serves as a third-party confirmation. Read More >>>


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