FDA Establishment Registration
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FDA Establishment Registration
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FDA Establishment Registration

FDA Establishment Registration Consulting. We are a US FDA Agent & consultant supporting worldwide manufactures & distributors simplifying very broad and often frustrating and complicated online FDA registration certificate 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 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 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.

Food Facility FDA Establishment Registration

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 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 U.S. ie; manufactures, distributors, owners, operators, or agents in charge are required to register the facility with the US FDA.

FDA Establishment Registration of Drug Facility

US Government(US FDA CDER) ensures safety and efficiency of the drugs that are available to mitigate diseases in patients 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 Registration of FDA 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 5 days of beginning operations.

In addition, FDA establishment Registration 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

FDA regulates the sale of Pharmaceuticals (OTC and prescription drugs) including biologicals and generic drugs.

Frequently Asked Questions.

Drug Establishment Registration.

Drug Facility Registration Fees.

Drug Registration Application Form.

FDA Registration of Medical Device Facility

Owners or operators involved in the manufacturing and Distribution of medical device(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 that are required to complete fda certificate of 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.

Application form.

Registration Fees.

4. FDA Registration of Cosmetic Facility

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

Voluntry Cosmetc Registration Programe applicable for manufactures and distributors of cosmetic products 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 about FDA Approval & FDA Certificate of Registration

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?

Customers and suppliers necesserly ask firms US FDA registration number and validity by their potential ciustomers/ suppliers to verify their FDA registration status . A Certificate of Registration issued by Our Company serves as a third-party confirmation. Read More. >>>

Recent Client Testiomonials.

I 3 Consulting Reviewed by Mr. Richard on . Best Consulting Company for FDA Establishment Registration Process. Thanks for your valuable support and services. Rating: 4.9

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