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?


  • 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.

The FDA detained my imported food… What can I do?

Under the Federal Food Drug & Cosmetic Act (FD&C Act) an article of food subject to a detention order may not be delivered to any of its importers, owners, or consignees.  To be clear, no person may transfer a detained article of food within or from the place where it has been ordered detained, or from the place to which it was removed, until an authorized FDA representative releases the article of food under or the detention period expires, whichever occurs first.  The transfer of an article of food in violation of a detention order is prohibited.

Can I Move my Detained Articles of Food?

Yes.  You have options!  The FD&C Act does not preclude all movement of detained food.  For example, at the FDA’s direction the imported food may be moved to a secure facility under an appropriate Customs’ bond, if required under the circumstances.  When the FDA issues an order detaining any article of food, a Notice of Detention (FDA 2289 Form) is issued to the custodian of the detained food and (if readily identifiable) the owner of the detained food.  Upon receipt of this notice, quick and informed steps need to be taken in order to minimize the impact of the detention.

An authorized FDA representative may approve, in writing, a request to modify a detention order to permit movement of a detained article of food for any of the following purposes:

(1) To destroy the article of food,

(2) To move the detained article of food to a secure facility under the terms of a detention order,

(3) To maintain or preserve the integrity or quality of the article of food, or

(4) For any other purpose that the authorized FDA representative believes is appropriate in the case.

21 C.F.R. 1.381(c).

As you can see, the importer possesses an arguably broad base for seeking a modification to a detention order.  Similarly, the FDA representative possesses broad authority to reject or deny your request.  This means that cooperation, professionalism, knowledge of your rights and a solid understanding of the FDA’s detention process is a MUST.

How to Modify a FDA Detention Order:

First, you must submit your request for modification of the detention order:

  • in writing and
  • to the authorized FDA representative who approved the detention order.

21 C.F.R. 1.381(d).  Importantly, the person who approved the detention order is identified in Box#17 of the Notice of Detention.  The FDA representative who approved the detention order is often NOT the same person who issued the Notice of Detention.  As a practical matter, a FDA Inspector issues the Notice of Detention and a FDA Compliance Officer approves the detention order.  Again, look at Box #17 on the Notice of Detention.

Secondly, you must state in your request:

  1. the reasons for movement;
  2. the exact address of and location in the new facility (or the new location within the same facility) where the detained article of food will be transferred;
  3. an explanation of how the new address and location will be secure, if FDA has directed that the article be detained in a secure facility; and
  4. how the article will be held under any applicable conditions described in the detention order.

Lastly, if you are requesting modification of a detention order for the purpose of destroying the detained article of food, you also must submit a verified statement identifying the ownership or proprietary interest you have in the detained article of food.

21 C.F.R. 1.381(d).

If FDA approves a request for modification of a detention order, the article may be transferred but remains under detention before, during, and after the transfer. FDA will state any conditions of transportation applicable to the detained article. You may not transfer a detained article of food without FDA supervision unless FDA has declined in writing to supervise the transfer. If FDA has declined in writing to supervise the transfer of a detained article, you must immediately notify in writing the authorized FDA representative who approved the modification of the detention order that the article of food has reached its new location, and the specific location of the detained article within the new location. Such written notification may be in the form of a fax, e-mail, or other form as agreed to by the authorized FDA representative.

21 C.F.R. 1.381(e).  Please note that the movement of detained food requires lots of separate written notices, approvals and other paperwork.  Care must be taken to keep your file as current as possible and to maintain copies of all the documents involved.  It is also important to properly identify all the relevant and necessary parties as their respective contact information will be needed to quickly and efficiently navigate this regulatory process.

Finally, you must ensure that any required tags or labels accompany the detained article during and after movement. The tags or labels must remain with the article of food until the FDA terminates the detention order or the detention period expires, whichever occurs first, unless otherwise permitted by the authorized FDA representative who approves the modification of a detention order under this section.

21 C.F.R. 1.381(f).

Take Away…

The key point here is that a solid understanding of your rights and the processes you must be prepared to navigate upon short notice is key to mitigating the risk to the value of your imported food.  Something as simple as quickly moving your perishable commodities from the port to a proper storage facility, as opposed to a shipping container, may make all the difference when it comes to your ability to sell your products post detention.