FSMA: Is There Penalty for Non-Compliance with a Recall Order?

YES!  The FDA may assess fees under Section 107 of the FSMA for non-compliance with a recall order under Section 423(d) or 412(f) of the FD&C Act. 

Non-compliance may include:

             1.         Not initiating a recall as ordered by the FDA

            2.        Not conducting the recall in the manner the FDA specifies in the recall order

            3.         Not providing the FDA with requested information regarding the ordered recall

Who Pays the fee for non-compliance with a recall order?

The party responsible for paying the non-compliance with a recall order fees include:

  • The responsible party for a domestic facility
  • An importer who does not comply with a recall order

The party paying the fee would be the party that received the recall order.  Importantly, this means that a distribution or storage company who owns or operates a food facility to provide services to others may be subject to this penalty even though they may not own the food. 

How much will a non-compliance with a recall order fee cost my company?

Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour is no foreign travel is required and $325.00 per hour if foreign travel is required.

Number of FDA employees or agents assigned to a reinspection: The FDA will make this determination on a case-by-case basis.  Relevant factors for this decision include the anticipated number of direct hours spent on taking action in response to the company’s failure to comply with a recall order.  

Billable Activities: conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition.

How can my company guard against or minimize its exposure to these  fees?

BE PREPARED!

  • Successful inspections are the result of comprehensive preparation.
  • Assess your company’s compliance with all relevant statutory and regulatory requirements.
  • Understand the FDA’s inspection process and know your rights at every stage
  • Be prepared to manage and control the inspection process… don’t let it control you.

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