There are two types of FDA Registration Renewal:
ANNUAL RENEWAL
- OTC Drugs Establishment Registration
- Prescription Drugs Establishment Registration
- Medical Devices Establishment Registration
- Cosmetics Establishment Registration
Current annual registration renewal is before December 31, 2022.
BIENNIAL RENEWAL
- Food Facility Registration
- Supplements Facility Registration
- Food Canning Establishment (FCE) Registration
However, the biennial registration renewal is required between October 1, 2022 and December 31, 2022.
Prepay now and avoid long queues on October 1, 2022.
REGISTER YOUR COMPANY, TODAY
ITB HOLDINGS LLC assists companies based in the United States, Canada, Mexico, Australia, India, China, Japan, South Korea, Russia, Portugal, Spain, Italy, France, Belgium, Netherlands, Germany, Sweden, Switzerland, United Kingdom, Ireland, among 100 countries.
We strongly suggest that you get a DUNS Number for your company.
FDA Registration Number or renewal, will be denied to companies without a DUNS Number.
Since getting a DUNS Number assigned by Dun & Bradstreet Inc and affiliated companies in the world is free, it is in your company’s best interest to act now before it is too late.
With the exception of food facilities, the registration renewals require the payment of User Fees to the U.S. Treasury.
Examples of User Fees are:
$5,672.00 annual, for medical devices establishment registration
- Monograph Drug Facility (MDF) Facility Fee: $24,178
- Contract Manufacturing Organization (CMO) Facility Fee: $16,119
annual, for OTC drug establishment registration.
Click here for a complete list of User Fees.
If you ship regulated products to the United States without renewing your company’s registration, the cargo will be detained by the U.S. Customs and the FDA. Therefore, make sure your registration is current, and not expired.
Perhaps, you may want to check the limited offer below. Discounts are also available for multiple registrations.
Save time and money, when you contact ITB HOLDINGS LLC, today.
- Manufacturer
- Exporter
- Importer
BIENNIAL
RENEWAL
$99.00