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U.S. Department of Health and Human Services

For Industry

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GDUFA Paid Facilities List


How to Interpret the Facilities List

Column

Description

Fiscal Year Satisfied

This field indicates the Fiscal Year for which the facility fee is being paid.

Facility Type
Satisfied

This field indicates the type of facility the coversheet was created and paid for. If you see a facility type in this field, it means that the facility in question has satisfied the user fee obligation associated with that type of business operation (API, FDF or both).  If a facility does *not* show a particular business operation, it means that the Agency has not received payment for that business operation.

Facility Name

This field indicates the name of the facility for which the coversheet was created and paid.

Facility Address

This field indicates the address of facility for which the coversheet was created and paid.

Facility FEI

This field indicates the FEI number for which the facility fee is being paid. This FEI number must match the address for the manufacturing facility. Please note that the FEI number must be a valid entry in order to capture the correct payment information; if an incorrect FEI is reported on the coversheet, the facility may wind up on the arrears list instead of this one.


Disclosure

The payment information contained in this file reflects entries retrieved from coversheets created and submitted by each payor. If the information contained in this file does not reflect your records, please contact the Agency via email at AskGDUFA@fda.hhs.gov to seek correction of your payment record.

Also, please note that the same facility may show up more than once due to incorrect submissions to the Agency; it does not indicate that the fee has been paid more than once.  For practical reasons it is difficult to remove these duplicate entries without significantly delaying updates to this list, so the Agency has decided to allow such duplicates to remain for now.

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Download the GDUFA Paid Facilities List

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