FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
FDA Registration Certificate & FDA US Agent
FDA Registration Certificate
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners. However, it’s necessary to understand that the official FDA does not provide registration certificates upon the completion of the registration. Instead, third-party companies like FDA Listing Inc. can issue registration certificates under certain conditions described below.
To issue a registration certificate, we first need to verify and validate your FDA registration. Additionally, we must update the registration information for foreign facilities to ensure our agency serves as a new U.S. agent. Below are the steps for U.S. agent appointment and issuing an FDA registration certificate for each type of registration
1) Food Facilities: We need your FDA registration number (FFR) and PIN code to verify your registration validity. The FDA number is 11 digits, and the PIN code is a combination of upperand lowercase letters and numbers generated by the FDA, which can be obtained from the last agent in charge of registration. Our service involves acting as your new US agent for foreign facilities. The food facility registration certificate has a one-year validity from the issue date.
Sample FDA Food Facility Registration Certificate
2) Cosmetic Facilities: To verify your cosmetic registration information, we must either access your FDA CDER account or 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 contains your facility brand name(s) and is valid during the current calendar year (i.e., 2024)
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 on the Device Establishment & Device Listing Site. The owner-operator number is an 8-digit number allocated by the FDA at registration. This service involves acting as a US agent for foreign device establishments. The device establishment registration certificate also contains device classification codes (3-letter class codes) and is valid during the current calendar year (i.e., 2024).
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 on the Drug Establishment Current Site. This service involves acting as a new US agent for foreign establishments, which means we need access to the original SPL registration file to update the record. The drug establishment registration certificate is valid during the current calendar year (i.e., 2024).
Sample FDA Drug Establishment Registration Certificate
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 FDA detention assistance service.
Service Details & Fees
FDA Registration Certificate
Time Required
U.S. Agent
FDA Registration Verification
FDA Registration Updates
245 USD
3-4 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
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).
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).
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).
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).
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).
Frequently Asked Questions (FAQ)
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).
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).
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).
Service Details & Fees
FDA Registration Certificate
245 USD
Time Required
3-4 Days
U.S. Agent
FDA Registration Verification
FDA Registration Updates
_______ Related Services _______