How to get US FDA Certificate in India?

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If you want to export products in the USA, you need to comply with certain US Import and Export Formalities. One such mandatory requirement you need to fulfill is US FDA Certification. It is a basic requirement that you need to export products such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, supplements, and even PPE Kit. Thus, it is important to get a US FDA certificate in India for every exporter exporting these products to the USA. In this article, you will get to know the complete process to get a US FDA Certificate in India.

What is the US FDA certificate in India?

FDA(Food and Drug Administration) is a US Government Agency. It was established under the Federal Food and Drugs Act.

The basic purpose of the US FDA is to protect and manage public health. Furthermore, the FDA works as a regulatory body. So, it ensures public safety by regulating the manufacturing, marketing, and distribution of a variety of products.

Thus, every exporter who wants to export products to the US or some other nation needs to apply for US FDA Certification. US FDA grants US FDA Certificate in India after a rigorous inspection.

Some other nations such as Japan, Brazil, Australia, and China also accept US FDA Certification. Hence, exporters in India need to apply for US FDA Certification in India order to export their medical products, cosmetics, Drugs, etc. to the USA and other countries.

Moreover, the US FDA is one of the oldest bodies for consumer protection. Therefore, the US FDA Certificate in India becomes a valuable asset for your business expansion across the globe.

Document Requirement for US FDA Certification in India

Document Requirement for US FDA Certification in India

Below are the documents required: 

  • Airway Bill & Invoice Bill of Lading
  • Order for Purchase
  • Specific Documentation for Each Commodity
  • List of Items to Consider
  • List of Growers
  • Labelling Copies
  • Documentation proving the identity of the product’s true owner
  • The declaration of the product’s intended or final usage
  • Any other documents which FDA requests during the process.

Complete process to get US FDA Certificate in India

The FDA has the power to investigate other nations’ facilities that export food and pharmaceutical items to the US. Food and pharmaceutical facilities operating in India that export goods to the U.S. need to mandatorily follow the FDA’s Current Good Manufacturing practices requirements (CGMP) in order to get US FDA Certificate in India. The complete process to get US FDA Certificate in India is as follows:

  • Easy and Free Consultation with our US FDA Certification Experts for understanding the requirements, eligibility criteria, and document preparation.
  • Choose a Package and Online Submission of the required documents on our web portal.
  • Our team will designate a US FDA Agent who is registered in the United States and then submit the application to the US Food and Drug Administration.
  • FDA Officials visit your manufacturing plant in India
  • After the FDA Department and US FDA Officials successfully inspect your business and get satisfactory verification, they will approve the import of the drug or any other product and we will deliver your US FDA Certification in India through your preferred online channel.

Take a call from Expert

Important Point: The time that takes to complete the verification procedure varies depending on the US FDA Department and its officers.

Is a full-time USA resident agent required for FDA certification in the United States?

All companies that do not have a presence in the United States must designate a registered US FDA Agent. According to the US FDA, the US FDA Agent must either be a US resident or have a permanent establishment or business premises in the US. Furthermore, the US FDA Agent should be registered in the United States.

Process of Company Registration in USA from India

If you want any other guidance relating to the US FDA Certificationplease feel free to talk to our business advisors at 8881-069-069.

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