Drug Establishment Registration also known as FDA registration is a mandatory requirement for facilities (establishments) involved in the manufacturing, propagation, testing, and packaging of finished and bulk drugs , including prescription and OTC drugs. Facilities must renew the registration between 1st October and 31st December every year. Failure to renew the registration may result in the cancelation of registration and such establishments will be removed from FDA establishment registration database. Foreign facilities are required to appoint a U.S. Agent for establishment registration purpose. The U.S Agent acts as the point of contact for the FDA to communicate with the foreign establishment.
In order 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 following information is required for completing an establishment registration.
Company name and complete address
Contact person name, telephone, and email
Information about the operations conducted at the facility
U.S Agent information for foreign facilities
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 U.S.
The FDA will assign an FEI number to new facilities after 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 FDA for current year.
FDAbasics can ease your compliance job by offering complete assistance for drug establishment registration in the shortest possible time frame.,. FDAbasics offers U.S 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 shortest time frame. We can also assist you for DUNS number application which is a mandatory requirement for FDA registration.
Drug Establishment registration – also referred to as drug firm annual registration or FDA registration – is a mandatory requirement for establishments that manufacture, processes or tests drugs, including finished dosage forms, bulk drugs, and OTC products for commercial distribution purpose in the United States. All the drug manufacturer who prepare propagate compound or process required to register within 5 days of starting operations, and they must renew their drug establishment registration between October to December each year.
FDAbasics offers a complete solution to support organizations through the Establishment registration and renewal processes. This 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 is approved 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 FDA.