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FDA REGISTRATION SERVICES

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.

Join thousands of satisfied clients in more than 100 countries. Reach millions more customers willing and able to buy your products.

ITB HOLDINGS LLC assists companies around the world with their FDA Registration needs, including manufacturers of hand sanitizers,  N95 masks and other COVID-19 (Coronavirus) personal protective equipment (PPE), as well as ventilators covered by Emergency Use Authorizations (EUA)s .

FDA Biennial Registration Renewal for domestic and foreign Food Facilities was required between October 1 and December 31, 2020. If you failed to renew your registration, you must now obtain a new FDA Registration Number.

  • Foreign Food Facility Registration
  • Domestic Food Facility Registration
  • U.S. Agent Service
$99.00 Annual Service Fee

WHY CHOOSE US?

■ More than 10 years of experience
■ Satisfied clients in 100 countries
■ SERVICES offered 7 days a week

For the following products requiring FDA RegistrationFoodsDietary Supplements, Alcoholic Beverages, Medical Devices, Medical Apps, Prescription Drugs, Over-the-Counter (OTC) Drugs, Active Pharmaceutical Ingredients (APIs), Cosmetics, Radiation-Emitting Products, Vaccines, Blood & Biologics, Animal & Veterinary Products.

    FDA NEWS

    FDA issued an EUA for the first over-the-counter, at-home, rapid diagnostic test for COVID-19. The Ellume COVID-19 Home Test, authorized for individuals 2 years old and older, with or without symptoms, detects proteins of the SARS-CoV-2 virus from a nasal swab sample. It can be used completely at home without a prescription and requires the use of a compatible smartphone and a downloadable app to provide testing instructions and deliver results in as little as 20 minutes.

    The U.S. Food and Drug Administration (FDA) is warning manufacturers, exporters, importers and distributors: Methanol is not an acceptable active ingredient for hand sanitizers and must not be used, due to its adverse events including deaths.

    Exporting Hand Sanitizers or PPEs? Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings. Make sure your DUNS Number is current.

    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    CURRENT FDA REGISTRATION TRENDS
    Food Facilities
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    Medical Devices
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    OTC Drugs
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