FDA Increases Reinspection Fees for 2014 FY

Posted by Juana Escobar on 8/2/13 5:04 PM

On a Federal Register notice published on August 2, 2013, the Food and Drug Administration (FDA) issued a notice announcing an increase in fee rates for the 2014 fiscal year (FY) for certain reinspections for foreign and domestic facilities, importers, and for failures to comply with recall orders.

According to the release, FDA will charge the following:

  • Base unit fee for reinspections and recall order fees excluding traveling expenses will be $221 per hour
  • Fees for reinspections of facilities where domestic travel is required will be $237 per hour
  • Fees for reinspections of facilities where international travel is required will be $302 per hour
  • Fees for failure to comply with recall orders will be determined based on the number of hours spent on taking action in response, following the above rate schedule

FDA explains that they will invoice the responsible party once the work has been completed, and payment must be received within 90 days. These fees will be effective on October 1, 2013 through September 31, 2014.

The Federal Register notice is available online here.

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