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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-389-7344
+1 855-510-2240
[email protected]

FDA REGISTERED COMPANY

EXPAND YOUR MARKET

fda registration services

As U.S. Agent, we register your domestic and or foreign company with the United States Food and Drug Administration (U.S. FDA). Contact ITB HOLDINGS LLC, today.

Domestic and foreign companies that are involved in the production and distribution of medical devices or drug products intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration (U.S. FDA). This process is known as establishment registration.

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: manufacturers, exporters, importers of medical devices, as well as sunscreens and active pharmaceutical ingredient (API), among many others.

Are you exporting or importing conventional food products, dietary supplements, canned food, instead? Simply contact us.

Food

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Medical

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Cosmetics

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Drugs

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Registration Services

For Domestic and Foreign Companies

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FDA COMPLIANCE

▪ FDA Establishment or Facility Registration and  renewal are required.
▪ Domestic and foreign companies are expected 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.
    FDA NEWS

    Medical Tourism: Treatments, Markets and Health System Implications.

    A growing trade in healthcare has involved the movement of patients across borders in the pursuit of medical treatment and health, a phenomenon commonly termed “medical tourism”.

    Anti-abortion group’s lawsuit alleges that the FDA’s approval for medication abortion drugs (mifepristone and misoprostol) from Danco Laboratories LLC, was unlawful and should be revoked.

    Temporary enforcement discretion for pending Unique Facility Identifiers (UFI) is no longer available. The option to select the “Pending UFI Option” for Food Facility Registrations has been terminated.

    As a result, FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

    Recalls, Market Withdrawals and Safety Alerts.

    Obesity continues to be a major health concern in the United States, with the disease estimated to have affected more than 40% of the population and cost nearly $173 billion annually.

    Domestic and foreign companies need to stop importing or exporting non-NIOSH-approved respirators. FDA revoked Emergency Use Authorizations (EUAs) of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators.

    Canada and the U.S. have a Food Safety Systems Recognition Arrangement (FSSRA). The Foreign Supplier Verification Program (FSVP) provides modified requirements to U.S. importers of food covered under the FSSRA from manufacturers in good regulatory standing with the Canadian Food Inspection Agency (CFIA).

    Radiation therapy is sometimes combined with hormone therapy (also called androgen deprivation therapy or ADT). Androgens such as testosterone are hormones that can cause prostate cancer cells to grow. ADT stops testosterone from being produced or directly blocks it from acting on prostate cancer cells. Hormone therapy may be given to patients with prostate cancer that has recurred after radiation or surgery and is the standard of care for men with cancer that has spread outside the prostate to other areas of the body (metastatic disease).

    www.m.itbhdg.com

    www.fda.itbhdg.com

    www.itbholdingsllc.com

    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 REGISTRATIONS TRENDS
    Food Facilities
    0%
    Medical Devices
    0%
    OTC Drugs
    0%

    The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months.

    3M Co has tentatively agreed to pay more than $5.5 billion to resolve over 300,000 lawsuits claiming it sold the U.S. military defective combat earplugs (regulated as medical devices by the FDA).

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    FDA REGISTRATION

    &

    FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)

    REGISTER NOW

    La registrazione FDA è un prerequisito per esportare cibo negli Stati Uniti. Sono 10.026 le aziende alimentari italiane iscritte alla FDA statunitense.

    El registro ante la FDA es un requisito previo para exportar alimentos a los Estados Unidos. Hay 4.611 empresas alimentarias españolas, así como 7.552 empresas mexicanas de alimentos, registradas ante la FDA estadounidense.