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FDA REGISTRATION

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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.

ITB HOLDINGS LLC assists companies around the world, including manufacturers of hand sanitizers, N95 respirators and other COVID-19 (Coronavirus) personal protective equipment (PPE) covered by Emergency Use Authorizations (EUAs) .

Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves.

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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 Registration: Foods, Dietary 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.

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FDA NEWS

Governments, trade groups and technology companies are offering ways of supplementing the paper vaccine cards issued by clinics and labs with a digital version that can be uploaded to a smartphone. The paper cards, approved by the Centers for Disease Control and Prevention (CDC), do not include a unique marker, number or QR code, making them easy to forge. New York is the only state with government-issued digital proof of COVID-19 vaccination or of a negative coronavirus test result, known as the Excelsior Pass.

FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents.

On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the United States. This change will become effective on January 1, 2023, so labeling of sesame as an allergen will not be required until that time.

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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

Medical Devices

OTC Drugs