FDA Establishment Registration

Are you involved in the manufacturing, propagation, testing, or packaging of drugs in the United States? If so, it is essential to understand the requirements for FDA registration, also known as Drug Establishment Registration. AF Pharma US is here to provide you with all the information and assistance you need to navigate the registration process seamlessly.

FDA Drug Establishment Registration is mandatory for facilities engaged in the production of finished and bulk drugs, including both prescription and over-the-counter medications, in accordance with 21 CFR 207. Even foreign establishments are required to appoint a US Agent for the purpose of establishment registration. This US Agent acts as the primary point of contact for the FDA to communicate with the foreign facility.

To ensure compliance, all drug manufacturers, compound preparers, and processors must register their establishments within five days of commencing operations. Furthermore, it is crucial to renew the drug establishment registration between October and December each year. Failure to renew the FDA registration may lead to cancellation, resulting in the removal of establishments from the FDA establishment registration database.

Who Needs to Register?

The FDA drug establishment registration process typically takes 4 to 5 working days to complete. However, if you are unfamiliar with the registration process, it may take longer. Here is the essential information required for establishment registration purposes:

• Name and complete address of the manufacturing, packaging, processing, or testing facility.

• Contact person's name, telephone number, and email address.

• DUNS number for the facility.

• Business operation information.

• US Agent information for foreign establishments.

Please note that drug establishment registration is distinct from FDA approval. Registration is a mandatory requirement for manufacturing, testing, processing, and packaging facilities. FDA approval, on the other hand, is necessary before a drug can be imported into the United States.

Obtaining an FEI Number

After successfully completing the establishment registration process, the FDA will assign an FEI (Facility Establishment Identifier) number to new facilities. You can verify the FDA registration status on the searchable database provided by the FDA. Prior to drug listing, it is crucial to ensure that the facilities mentioned in the listing are registered with the FDA for the current year.

AF Pharma US can assist you in obtaining an FEI number for self-identification purposes in the shortest possible time. It is important to note that an FEI number is not required for shipment clearance. If you are already registered with the FDA but do not have an FEI number, your DUNS number can be used for shipment clearance purposes at the port of entry.

AF Pharma US is dedicated to providing comprehensive assistance for drug establishment registration within the shortest possible time frame. Our services include US Agent appointment, registration services, and guidance throughout the process. We also assist with the DUNS number application, a mandatory requirement for FDA registration.

We pride ourselves on offering competitive fees without compromising the quality of service. Our complete solution supports organizations through the establishment registration and renewal processes. Our services include obtaining a DUNS number, acquiring the FEI number, and preparing and submitting the Establishment Registration. We continue to support you until your registration status appears on the FDA website.

Choose AF Pharma US for FDA Registration Assistance

Why should you choose AF Pharma US for your FDA Registration Assistance? Here are the reasons:

1. Low price guarantee and fast processing.

2. No hidden fees or increased fees for annual renewal.

3. Discounted rates for multiple facilities.

4. Free assistance for obtaining DUNS and FEI numbers.

5. No extra charges for changes to your registration.

Please be aware that the FDA does not issue certificates for completed registrations. You can verify the current registration status of drug establishments on the FDA website. Certificates issued by consulting firms are not recognized by the FDA.

AF Pharma US is your best choice for US Agent for FDA Drug Establishment Registration Services and Renewal Process. With our expertise and dedication to excellence, we ensure a smooth and efficient registration experience. Contact us today to get started on your registration journey.