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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA

 

REGISTRATION RENEWALS

 

Domestic and Foreign Companies in over 100 countries

 

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FDA
REGISTRATION RENEWAL

There are two types of FDA Registration Renewal: Annual and Biennial.

A DUNS Number is required for annual and biennial registrations.

The FDA recognizes the DUNS Number as the only acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.

FDA Registration Number or renewal, will be denied to companies without a DUNS Number.

ANNUAL REGISTRATION RENEWAL

▪ OTC Drugs Establishment Registration

▪ Prescription Drugs Establishment Registration

▪ Medical Devices Establishment Registration

▪ Cosmetics Establishment Registration

Current annual registration renewal is before 11:59 PM on December 31, 2024.

BIENNIAL REGISTRATION RENEWAL

▪ Food Facility Registration

▪ Supplements Facility Registration

▪ Food Canning Establishment (FCE) Registration

However, the biennial registration renewal is required between October 1, 2024 and December 31, 2024.

USER FEES

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:

Medical Devices
$7,653 annual for medical establishment registration.

Over-the-Counter (OTC) Establishments

  • Monograph Drug Facility (MDF) Facility Fee: $26,153
  • Contract Manufacturing Organization (CMO) Facility Fee: $17,435

Click here for a complete list of User Fees.

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SAVE TIME & MONEY

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.

REGISTER YOUR COMPANY OR SWITCH U.S. AGENT, TODAY

Payment Options are: Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, Paypal, SEPA Direct Debit, Stripe, Payments in multiple currencies.

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Drug Establishment
$350.00
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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.

SWITCH U.S. AGENT

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.

FOOD FACILITY REGISTRATION
  • Manufacturer
  • Exporter
  • Importer
LIMITED OFFER

ANNUAL |
BIENNIAL
RENEWAL

$99.00

CONTACT ITB HOLDINGS LLC