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.
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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) 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
The Data Safety Monitoring Board expressed concern that AstraZeneca may have included outdated information from the trial results of its Covid-19 vaccine, potentially casting doubt over published efficacy rates, the U.S. National Institute of Allergy and Infectious Diseases said.
U.S. trial results showed that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization.
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.
FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
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.