How to Get US FDA Certificate In India?

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Are 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 fulfil 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.

The 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 a US FDA Certificate in India. The complete process to get a US FDA certificate in India is as follows:

process to get us fda certification in India

  • Classify Your Product: Identify if your product is food, drug, device, or cosmetic under FDA regulations.
  • Facility Registration: Register your facility via the FDA’s online system and appoint a U.S. agent.
  • Meet Compliance Standards: Follow specific FDA requirements for your product type (e.g., FSMA, GMP, 510(k)).
  • Submit Product Listings: Add your product to the FDA database with required details.
  • Prepare Documentation: Provide licenses, GMP certificates, and testing reports.
  • Obtain Certification: Receive your FDA certification upon successful compliance.
  • Maintain Compliance: Renew registrations and update listings regularly to stay compliant.

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

Document Requirement for US FDA Certification in India

Document Requirement for US FDA Certification in India, Document for US FDA Certification, US FDA Certificate In India, How to Get US FDA Certificate 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 the FDA requests during the process.

Q- 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.

How to verify US FDA Certification?

Take a call from Expert

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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