FDA Establishment Identifier (FEI) NUMBER

fda registration services

The FEI is a number assigned by the FDA upon initial registration and is used in certain submissions and communications with FDA. The FEI can also help track inspections of FDA regulated establishments or facilities.

Dun & Bradstreet Inc (D&B) is a common source of commercial information on businesses. D&B maintains a database of Data Universal Numbering System (DUNS) numbers, which serve as unique identifiers of business entities globally. Upon application, each company is assigned a distinct site-specific 9-digit DUNS number.

FDA is currently using the DUNS number as the Unique Facility Identifier (UFI) required for Registration and Listing submissions.

Therefore, all manufacturers, exporters, importers and distributors are now expected to have one.

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FDA COMPLIANCE
Is your company’s software intended for use by trained blood banking laboratory personnel for managing patient information, blood transfusion requirements, blood specimen test orders, laboratory test results, blood product orders (including safety/compatibility checks for attributes, antibodies, and antigens), and patient transfusion histories?

    Help Save Lives

    Labeling misbrands a product if:

    • Its labeling is false or misleading in any particular
    • It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
    • The establishment is not registered with the FDA as required

     

    Food Facilities
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    Medical Devices (PPEs)
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    OTC Drugs (Hand Sanitizers)
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