FDA Updates GDUFA Paid Facilities List, Flagging FEI Errors That Trigger Arrears Classification

Generic drug manufacturers risk arrears classification on the FDA's GDUFA Paid Facilities List not from missed payments, but from a single data entry error, an incorrect FEI number on the fee coversheet. The Agency's updated list, published May 21, 2026, carries a pointed disclosure: appearing on the payments list does not confirm that a facility has fully satisfied its user fee obligations under 21 U.S.C. § 379j-42(a)(4)(A).

The compliance exposure is specific. If the FEI number submitted on a coversheet does not match the address of the actual manufacturing facility, FDA may apply the payment incorrectly, moving the facility onto the arrears list regardless of whether funds were received. For QA directors and regulatory affairs leads managing multi-site portfolios, that distinction carries direct inspection-readiness consequences: arrears status can affect a facility's standing in the generic drug submission review queue.

The list tracks three facility payment types, API, FDF, and CMO, each requiring a separate coversheet. Absence of a payment type on the list means FDA has not recorded receipt for that category, not necessarily that the fee was unpaid. Facilities subject to fees include those identified in at least one approved or pending generic drug submission to produce a finished dosage form or active pharmaceutical ingredient, as defined under both GDUFA I (2012) and GDUFA II (2017).

A secondary data integrity issue is also documented: duplicate facility entries appear on the list due to incorrect prior submissions. FDA has confirmed it will not remove these duplicates, citing update-delay concerns, so facilities should not interpret a repeated listing as evidence of double payment or full compliance.

Plant heads and regulatory leads should cross-reference their internal payment records against the downloadable XLS file, available at 3 MB, and verify that each site's FEI number on submitted coversheets matches the registered facility address exactly. Discrepancies should be reported directly to AskGDUFA@fda.hhs.gov for correction before the next fiscal year cycle opens.

With the fiscal year cycle advancing, facilities that identify FEI mismatches now have a narrow correction window before arrears classification affects their regulatory standing and submission review timelines.

Source: FDA via What's New: Drugs RSS Feed, May 21, 2026.