FDA Establishment Registration
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FDA Establishment Registration
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US FDA Registration in India

US FDA Registration processvaries dependent on the type of product but generally involves an annual or biannual, if commercially available, for Distribution in the US Market.

We are a US FDA registration Consultant supporting worldwide manufacturers & distributors simplifying a comprehensive and often frustrating and complicated online US FDA Registration Certificate and listing formalities.

US FDA Registration

US FDA (Food and Drug Administration)

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 Equipments, and Tobaccos by regulating the manufacturing, marketing, and distribution.

Owners or operators of places of business (also called FDA ESTABLISHMENTS or FACILITIES) that Manufacture, Repack, Relabel, Export or Import products in the aforementioned industries must REGISTER their facilities with the US FDA.

The FDA Registration process varies depending on the type of product but generally involves an annual or biannual, if commercially available, distribution in the US.

Food Facility FDA Registration & Establishment

US FDA Food Registration is valid 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 US food supply and other food-related emergencies.

To comply with the above provisions of the Bioterrorism Act, FDA established the 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."

Those who are responsible for the sale of food for consumption in the USA, i.e., manufacturers, distributors, owners, operators, or agents in charge, are required to register the facility with the US FDA.

US FDA Registration of Drug Facility

US Government (US FDA CDER) ensures the safety and efficiency of the drugs available to mitigate diseases in patients in the United States.

Domestic and Foreign establishments that manufacture, repack, or re-label drug products for marketing in the United States are required to complete FDA Registration and followed by listing 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), Registration must be completed within five days of beginning operations

Also, FDA establishment Registration must renew US FDA annually between October 1 and December 31 of each year.

Type of Drugs are the following:

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

FDA regulates the sale of Pharmaceuticals (OTC and prescription drugs), including biological and generic medications.

FDA Registration of Medical Device Facility

Owners or operators involved in the manufacturing and distribution of medical devices (a) intended for use in the United States, including those that are imported for export only, are required to complete annual Registration of FDA.

As per CFR 807, most of the establishments required to complete FDA Certificate of Registration are also required to list the Medical Devices.

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

FDA Registration of Cosmetic Facility

As per US FDA Cosmetic Facilities has to complete Registration as per the Voluntary Cosmetic Registration Program (VCRP).

Manufacturers, packers, and distributors of cosmetic products in commercial distribution in the United States have to report via a system called VCRP.

Voluntary Cosmetic Registration Program is applicable for manufacturers and distributors of cosmetic products sold to consumers in the United States.

VCRP does NOT apply to cosmetic products for professional use only in skincare clinics or cosmetics, not for sale, and for cosmetics you make in your home to give to your friends.

How to achieve FDA Certificate and Approval?

FDA never approves any health care product manufacturer. FDA has the authority to inspect facilities to verify that they comply with applicable proper manufacturing practice regulations.

Customers and suppliers necessarily ask firms US FDA registration number and validity by their potential customers/ suppliers to verify their FDA registration status.

A Certificate of Registration issued by Our Company serves as a third-party confirmation.

Useful FDA Links:


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