FDA Registration Certificate & FDA US Agent

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How to Get an FDA Registration Certificate?

An FDA Registration Certificate issued by FDA Listing Inc. is a third-party document that confirms the FDA registration information we have verified for the applicable facility or product. It may be used as a business document for customers, distributors, retailers, or other commercial partners who request confirmation of FDA registration-related information.

However, an FDA Registration Certificate is not issued, approved, endorsed, or certified by the U.S. Food and Drug Administration. Furthermore, FDA registration, listing, or a registration number does not demonstrate FDA approval, clearance, authorization, or full regulatory compliance for a facility or product.

To issue an FDA Registration Certificate, we first verify and validate the applicable FDA registration information. For foreign facilities, we also update the registration information, where applicable, to designate FDA Listing Inc. as the new U.S. Agent. The following steps outline the process for U.S. Agent appointment and FDA Registration Certificate issuance for each registration type.

1) Food Facilities: We need your FDA registration number (FFR) and PIN code to verify your registration. The FDA registration number is 11 digits, while the PIN code is a combination of uppercase and lowercase letters and numbers generated by the FDA. The PIN code can be obtained from the last U.S. Agent responsible for the registration.

Our service includes acting as your new U.S. Agent for foreign facilities. The Food Facility Registration Certificate is valid for one year from the date of issuance.

Sample FDA Food Facility Registration Certificate

2) Cosmetic Facilities: To verify your cosmetic registration information, we must either access your FDA CDER account or obtain the original SPL registration file. This service involves acting as an additional correspondent for your facility registration, in addition to your firm’s contact person. The Cosmetic Facility Registration Certificate also includes your facility brand name(s) and is valid for the current calendar year.

Sample FDA Cosmetic Facility Registration Certificate

3) Medical Device Establishments: To verify your device registration information, we need access to your FDA FULRS account or your establishment owner-operator number to confirm your valid registration through the Device Establishment & Device Listing Site. The owner-operator number is an 8-digit number assigned by the FDA at the time of registration. This service involves acting as the U.S. Agent for foreign device establishments. The Device Establishment Registration Certificate also includes device classification codes (3-letter class codes) and is valid for the current calendar year.

Sample FDA Medical Device Establishment Registration Certificate

4) Drug Establishments: To verify your drug establishment registration, we must access your FDA CDER account or have your FDA-issued FEI number and your company’s legal name to confirm the registration through the Drug Establishment Current Site. Furthermore, for foreign establishments, our service involves acting as the new U.S. Agent, which requires access to the original SPL registration file to update the record. The Drug Establishment Registration Certificate is valid for the current calendar year.

Sample FDA Drug Establishment Registration Certificate

What is the Role of FDA U.S. Agent ?

The U.S. FDA mandates that companies outside the United States that manufacture food and beverages, cosmetics, medical devices, and drugs must appoint a U.S. Agent when registering with the FDA for communication purposes. This U.S. Agent must have a permanent address within the United States. As your designated U.S. Agent, we not only handle communications with the FDA on your behalf but also offer the following services:

● Guide you with your questions regarding the FDA’s new regulations.

● Updates to your FDA Registration, such as product or address updates.

● Ensuring that your identification numbers, such as unique facility identifier (UFI) or FDA establishment identifier (FEI), are accurate and up-to-date.

● Support with the release of detained shipments via the FDA detention assistance service.

Service Details & Fees

245 USD

3-4 Days

_______ Related Services _______

Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

FDA Registration Certificate

245 USD

Time Required

3-4 Days

U.S. Agent

FDA Registration Verification

FDA Registration Updates