FDA Sets Fees for FSMA Reinspections, Penalties

WASHINGTON — The Food and Drug Administration has determined fees for the 2014 fiscal year for certain facility reinspections and penalties related to the Food Safety Modernization Act.

The reinspection fee applies to domestic and foreign facilities that manufacture, process, pack or hold food for consumption that have failed a previous inspection due to a food safety issue. Domestic facilities and importers that fail to comply with an FDA recall will also be subject to a fee.


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The fees amount to $237 per hour for FDA actions within the U.S. and $302 per hour for actions outside the U.S.

The 2014 fiscal year runs from Oct. 1, 2013 to Sept. 30, 2014.

The fee notice is scheduled to be published in the Federal Register on Aug. 2.

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