Q8. What is the penalty for failure to pay a facility fee?
There are several consequences for failure to pay a facility fee. No new generic drug submission referencing the facility will be received until the fee is paid. In addition, the facility will be placed on a publicly available arrears list if the fee is not fully paid within 20 days of the due date. And, FDA will notify the ANDA applicant of the facility’s failure to satisfy its user fee obligations. Furthermore, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility will be deemed misbranded. This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products misbranded because of failure to pay facility fees are subject to being denied entry into the United States.
Note: The fee is an obligation to the U.S. government, and the failure to pay the fee may result in collection activities by the government pursuant to applicable laws.
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