The US FDA Certificate holds significance as customers and suppliers often require it to validate the registration number and registration validity date, especially for food manufacturers and exporters.
Companies worldwide, including manufacturers, exporters, and traders, want to include the term “FDA Certified” in their company name. However, it is crucial to note that the FDA only issues certificates to domestic manufacturing companies and not to any other organization.
For products regulated by the Food and drug administration, domestic firms exporting from the United States may be asked by their foreign customers or foreign governments to provide a “US FDA Certificate.” This document, prepared by the US Food and Drug Administration, contains relevant information about a product’s regulatory or marketing status.
We are a team of US FDA Agents and regulatory consultants with offices in the USA, Germany, and India. Our services provide certificates that serve as third-party confirmation of your registration status.
It’s crucial to understand that the third-party FDA Certification does not hold legal validity, nor does the US FDA recognize it as an official certificate of Registration.
To obtain a certificate, you can reach out to us by writing an email or submitting the quick contact form provided on the left side.
The fees for our US FDA Certification start at 350 USD, which may vary depending on the product and its type. We strive to organize the certificate within six hours during working days.
The FDA Food Facility Registration is confidential, and the FDA does not disclose registrant information to the public. Therefore, potential buyers from the USA may request additional information, such as login details or the FDA Agent-issued FDA Certification.
The US FDA Certificate issued by a US Agent remains valid for one year from the issue date. However, the validity period can be extended upon request and payment.
It is necessary to understand that using the term “FDA Approved” on primary labels, secondary packages, and websites for commercial purposes is incorrect. The US Food and Drug Administration does not accept such statements.
The FDA does not approve manufacturers for any activity. However, it does approve new medical devices and certain high-risk medical devices. The FDA also approves new drugs and biologicals before allowing companies to market those items. However, the FDA does not approve Food, Cosmetics, OTC, and Compounded drugs.
Now, moving on to the frequently asked questions:
The Food and Drug Administration issues a US FDA Certificate to domestic manufacturers to ensure the smooth acceptance of US products in other countries.
FDA Certification cannot be obtained directly from the US FDA. As FDA Agents, we issue certificates after the facility or establishment is registered with the FDA using our US Agent Service.
FDA Color Certification is required for all colour additives, except coal tar hair dyes, before they can be used in food, drugs, or cosmetics. It is issued after thorough analysis at designated facilities by the FDA based on test results.
The validity of an FDA Certificate issued by a US Agent is one year from the initial issue date.
The cost of FDA approval varies depending on the products. For detailed information, please contact us.
Lastly, it is crucial to understand that since the FDA does not issue certificates, you cannot advertise your facility as FDA Certified.