Background

FDA announced FY 2024 (October 1, 2023 through September 30, 2024) fees as follows:

  • Hourly fee rates for domestic and foreign facility re-inspections, failures to comply with a recall order, and importer re-inspections: 1) if domestic travel is required: $291/hour 2) if foreign travel is required: $312/hour. This fee will be based on the number of direct hours spent on such re-inspections, including time spent conducting the physical surveillance and/or compliance reinspection at the facility, or whatever components of such an inspection are deemed necessary, making preparations and arrangements for the reinspection, traveling to and from the facility, preparing any reports, analyzing any samples or examining any labels if required, and performing other activities until the facility is again determined to be in compliance.
  • Annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program: (VQIP) of $14,975.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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Independent FDA Regulatory and Strategic Consultant

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