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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.

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 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 Registration. Click on link below.

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

    New York startup raises $33M for fertility treatment based on Harvard University geneticist George Church’s lab stem cell research. Women hop­ing to con­ceive through in vit­ro fer­til­iza­tion of­ten un­der­go two weeks of gru­el­ing hor­mone in­jec­tions to ma­ture and col­lect eggs. Gameto Inc hopes to dramatically reduce or eliminate those injections, and their side effects such as headaches, nausea, and pain, by maturing eggs in a lab dish.

    Eli Lilly & Co will spend $5.3 billion to boost manufacturing capacity for its hot-selling anti-obesity drug Zepbound and diabetes drug Mounjaro, a huge investment to ease shortages of the popular drugs.

    FDA approves first at-home sterile over-the-counter kit to help with infertility, and for use in intravaginal insemination (IVI). It is designed to be used with either a fresh or cryogenically frozen donor semen sample, when intercourse isn’t working or isn’t an option.

    When shipping your products to a U.S. Amazon warehouse, don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, United Kingdom, are the same or similar.

    Under the federal Trade Agreements Act, goods sold to the U.S. military or federal government purchasers must be made in America or certain designated foreign countries. China is not one of them.

    A shampoo is a cosmetic, since its intended use is to cleanse the hair.

    An anti-dandruff treatment is a drug, because its intended use is to treat dandruff.

    Consequently, an antidandruff shampoo is both a cosmetic and a drug.

    La Registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti e ti costa solo ora €93.00. Più di 10026 aziende alimentari italiane sono registrate presso la FDA degli Stati Uniti.

    4217 से अधिक भारतीय खाद्य कंपनियां युनाइटेड स्टेट्स एफडीए के साथ पंजीकृत हैं।.

    FDA is not precluded from taking action against any dietary supplement containing new dietary ingredient if it is found to be unsafe, adulterated, or misbranded.
    Food Facilities
    Medical Devices
    OTC Drugs

    FDA approved two milestone treatments – the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.

    If you are not located in the United States, products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States.

    The U.S. FDA may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.