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LOWEST FDA REGISTRATION SERVICE FEES

In response to concerns relating to insufficient supply and availability of face masks, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for face masks use by members of the general public and health care personnel (HCP), as personal protective equipment (PPE),  during the Coronavirus Disease 2019 (COVID-19) pandemic.

Is your company manufacturing, exporting, importing or distributing personal protective equipment (PPE) or hand sanitizers?

Are you considering shipping food products, medical devices, drug products or cosmetics to the United States?

The FDA oversees more than 36.9 million shipments of regulated products from over 150 countries to 130,000 U.S. importers. These products are manufactured, processed, or packaged at more than 300,000 foreign facilities.

The registration of your facility or establishment with the FDA is required, and ITB HOLDINGS LLC is ready to assist.

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■ Domestic and foreign companies are required to have a DUNS (Data Universal Numbering System) Number issued by Dun & Bradstreet Inc to all types of business organizations including sole proprietorships, corporations, partnerships, non-profits, and government entities.

$99.00 for Food Facility Biennial Registration Renewal of 2020. Click on link below.

    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings.
    FDA NEWS

    The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) examine serious side effect, including spinal cord damage of a participant, in COVID-19 vaccine trial that was halted.

    AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, indicated that the volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

    Pfizer Inc to seek Emergency Use Authorization (EUA) approval from the U.S. Food & Drug Administration for its COVID vaccine in November. FDA requires that companies provide two months of safety data on half of trial participants following the final dose of the vaccine.

    As with any type of personal protective equipment (PPE), the key to proper selection and use of gowns and coveralls, is to understand the hazards and the risk of exposure.
    Food Facilities
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    Medical Devices (PPEs)
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    OTC Drugs (Hand Sanitizers)
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