This list contains GDUFA facility payments received by the Agency. The following table explains the terms used in the list:
|Fiscal Year||The Fiscal Year for which the facility fee is being paid.|
|Facility Name||The name of the facility for which the coversheet was created and paid.|
|Facility Address||The address of facility for which the coversheet was created and paid.|
|Facility FEI||The FEI number for which the facility fee is being paid. This FEI number must match the address for the actual manufacturing facility. 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 be placed on the arrears list instead of the payments list.|
||The type of facility or business operation the coversheet was created and paid for. There are three different business operations for which a payment can be made—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.|
The payment information contained in this file reflects coversheets created and submitted in the User Fee System by each payor. The appearance of a facility on the GDUFA Facility Payments List does not indicate that a facility has fully satisfied its user fee obligations. The facility is required to complete the self-identification process and pay the fee for all applicable fiscal years the facility is identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce a human generic API, FDF, or both.
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.
Please note that the same facility may show up more than once due to incorrect submissions to the Agency; this 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. The Agency has decided to not to remove such duplicates.
For additional information regarding GDUFA requirements, please visit the GDFUA main website at www.fda.gov/gdufa