As per 21 CFR 207 Drug Establishment Registration, also known as FDA registration, is a mandatory requirement for facilities involved in the manufacturing, propagation, testing, and packaging of finished and bulk drugs, including prescription and OTC drugs.
Additionally, foreign facilities are required to appoint the US. Agent for establishment registration purposes. The US Agent acts as the point of contact for the FDA to communicate with the foreign establishment.
FDA Drug Establishment registration is a mandatory requirement for establishments that manufacture, process, or test drugs, including finished dosage forms, bulk drugs (API), and OTC products for commercial distribution purposes in the United States. All the drug manufacturer who prepares propagate compounds or processes are required to register within five days starting operations, and they must renew their drug establishment registration between October to December each year. Failure to renew the FDA registration may result in the cancelation of registration, and such establishments will be removed from the FDA establishment registration database.
To complete the FDA drug establishment registration process, it takes 4 to 5 working days. If you are not familiar with the registration process, it may take more time.
The below-listed information is required for establishment registration puposes
Please note, drug establishment registration and FDA approval are two different aspects; registration is one of the mandatory requirements for manufacturing, testing, process, and packing facilities. However, FDA approval is required before a drug can be imported into the US.
The FDA will assign an FEI number to new facilities after the successful completion of establishment registration. You can verify FDA registration on a searchable database designed by the FDA. Before drug listing, you must make sure that the facilities mentioned in the drug listing are registered with the FDA for the current year.
FDAbasics shall help you to obtain an FEI number for self-identification purposes within the shortest possible time.
FEI number is not required for your shipment clearance purposes; if you are already registered with the FDA and do not have an FEI number, then your DUNS number can be used for shipment clearance purposes at the port of entry.
FDAbasics can ease your compliance job by offering complete assistance for drug establishment registration in the shortest possible time frame. FDAbasics offers US Agent and registration services at competitive fees with the highest quality of service.
If your shipments are on hold due to noncompliance with FDA registration and listing requirements, FDAbasics offers prompt services within the shortest time frame. We can also assist you with the DUNS number application, which is a mandatory requirement for FDA registration.
FDAbasics offers a complete solution to support organizations through the Establishment registration and renewal processes. Our FDA registration assistance includes assistance with obtaining a DUNs number, obtaining the FEI number, and the preparation and submission of the Establishment Registration. We continue to support you until your registration status appears on the FDA website.
There are no FDA charges for registration, so we can keep our fees low, at just $299. It takes four working days to complete establishment registration. We also offer discounts for multiple facility registration.
As with other elements of the drug registration process, the FDA does not issue certificates for a completed registration. You can verify drug establishments’ current registration status on the FDA website. Certificates issued by consulting firms are not recognized by the FDA.