Thursday, August 1, 2013

FDA proposes fee structure for re-inspections and recalls as part of FSMA

As part of the provisions in FSMA, FDA is setting a fee schedule for re-inspections of a facility when that facility had non-compliance/food safety issues during the initial inspection and for conducting a recall when the company fails to comply with a recall order.

For 2014 (which begins Oct 1, 2013), the fee rate is $237 an hour ($302 when foreign travel is required).

So for an all day visit (8 hours - arriving at 8 am and leaving at 4 am, no lunch), a facility is looking at a roughly a $1900 bill from Uncle Sam. Their goal will be to determine that corrective action was aken to resolve the noncompliance issue. Hopefully they can be convinced actions in 30 minutes the the corrective action was successful.

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