For Industry

Reconditioning

Overview

When a product is detained because it violates FDA laws and regulations, the importer of record may submit an application to FDA requesting permission to re-label or recondition the product in an attempt to bring it into compliance.

FDA has the authority to grant or deny an application to recondition.

Steps for the reconditioning process

  1. Submission of Form FDA 766
    • Who should submit the Form FDA 766?
      The importer of record (person holding the bond) should fill out and submit the Form FDA 766 to the compliance officer listed on the Notice of FDA Action.
    • What should be included with Form FDA 766?
      Form FDA 766 should include the estimated timeframe for which the reconditioning will be completed as well as a detailed summary of how the product will be brought into compliance. If your reconditioning proposal includes new labeling, please include a copy of this label with your proposal.
  2. FDA’s review of your proposal
    The FDA compliance officer will review the adequacy of the proposed reconditioning plan. If necessary, the compliance officer will send the application to a subject matter expert at one of FDA’s centers. The proposal is reviewed and a determination is made to grant or deny the proposal.
    • Why would FDA deny my application?
      FDA may deny the application if the proposed reconditioning does not provide FDA with the confidence that the product will be brought into compliance.  Reasons for denial may include but is not limited to:
      • Failure of the reconditioning application to demonstrate it will correct the violation.
      • Submitting a second application to recondition without meaningful changes to the reconditioning operation.
      • Submission of third application to recondition.
      • Lack of information, including revised labeling, description of reconditioning process, etc.  The application should provide all information identified by regulation.
      • Applicable center denies reconditioning proposal based on center review.
      • FDA policy or regulations prohibit the proposed reconditioning operations. For example, reconditioning of product detained for unapproved new drug charge.  (See Regulatory Procedures Manual Section 9-12)
      If your application is denied, the compliance officer will issue a Notice of FDA Action indicating the denial. This notice will inform you whether another application may be submitted.
  3. Completion of reconditioning
    If FDA approves your reconditioning application, the reconditioning must be completed within the specified timeframe. Once completed, you must notify FDA that the products are available for examination.
  4. Verification of reconditioning
    The reconditioning verification is conducted by FDA at the expense of the Importer to allow for FDA to verify that the reconditioning has been successfully completed.

    Once the FDA investigator has verified the reconditioning, and if the reconditioning is successful, your product will be released. If the examination reveals that the reconditioning was not successful, your product may be refused. 
  5. If my reconditioning was not successful, may I submit another reconditioning application?
    If the reconditioning was not successful, you may submit a second application if desired. This application will not normally be approved unless it contains meaningful changes in the reconditioning operation to ensure a reasonable chance at successful reconditioning. A second application will not be approved if it is merely a resubmission of the original application. 

    Request for a third attempt at reconditioning will generally not be granted. It is FDA’s opinion that to allow unlimited attempts at reconditioning only encourages importers to import violative merchandise into the U.S. A refusal of an entry may be issued if there have been multiple reconditioning proposals previously denied for that entry.
  6. What happens if I am unable to successfully recondition the entire shipment?
    FDA may issue a partial release/partial refusal if part of the shipment is successfully reconditioned.  You will receive a Notice of FDA Action that will identify the portion of the shipment that was successfully reconditioned so it can be released.  The Notice of FDA Action will also identify the portion of the shipment that was not brought into compliance and refused.
     

Supervisory Charges

At the time you submit the Form FDA 766, you agree to pay for all supervisory costs in accordance with current regulations.  These can include, but are not restricted to:  travel expenses for the FDA supervising officer; per diem for the FDA supervising officer when away from his or her home station; services of the FDA supervising officer; and services of the FDA analyst if necessary. 

You will receive instructions from CBP on where to send the payment for the costs associated with verifying the reconditioning.

For more information on supervisory charges associated with reconditioning your product review the Regulatory Procedures Manual, Section 9-13, Supervisory Charges.
 

Who do I contact about reconditioning?
Contact the FDA compliance officer listed on your Notice of FDA Action.


 

Page Last Updated: 01/16/2018
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