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USA DUNS-FDA REGISTRATION

America DUNS FDA Registration involves two separate concepts: DUNS Number and FDA Registration. Let's explain them individually:

1. DUNS Number:

  • DUNS (Data Universal Numbering System) is a unique nine-digit numbering system operated by Dun & Bradstreet (D&B) used to identify businesses worldwide.

  • It serves as a kind of global identification number for businesses.

  • Many institutions and organizations, especially companies wishing to do business with the U.S. federal government, require a DUNS number.

  • Companies that will do business with the FDA (U.S. Food and Drug Administration) generally also need to obtain a DUNS number.

  • The DUNS number allows your business to be registered in the D&B database and provides access to data such as credit history and financial information.

2. FDA Registration:

  • The FDA (U.S. Food and Drug Administration) is a federal agency responsible for overseeing the safety and effectiveness of food, drugs, medical devices, cosmetics, biological products, radiation-emitting electronic products, and tobacco products in the United States.

  • Facilities engaged in manufacturing, processing, packing, or holding these products in the U.S. are required to register with the FDA.

  • FDA registration is done in different categories depending on the type of product and the field of activity (e.g., food facility registration, drug facility registration, medical device facility registration).

  • FDA registration does not mean that the product is approved by the FDA. Registration indicates that the FDA is aware of your facility and your activities. You may need to go through separate approval processes to prove that your products are safe and effective.

America DUNS FDA Registration generally indicates that a business operating in the U.S. related to products under the FDA's jurisdiction (manufacturing, processing, packaging, holding, etc.) has both obtained a DUNS number and registered with the FDA. In other words, the business has a globally recognized identification number (DUNS) and its activities are monitored by the FDA.

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