U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. Import Program – Food and Drug Administration (FDA)
  4. Actions & Enforcement
  5. Import Alerts
  6. Removal from Import Alert
  1. Import Alerts

Removal from Import Alert

Overview

This page provides an overview of FDA’s procedures for removing a product and/or foreign manufacturer from detention without physical examination (DWPE) status, or from Import Alert.

How can I request removal from a red list or addition to a green list of an Import Alert?

In order for FDA to consider removing a product and/or firm from DWPE, FDA must have evidence that the conditions that gave rise to the apparent violation have been resolved and that gives FDA confidence future entries will be in compliance with FDA laws and regulations.

You may submit a petition to DIO for removal from DWPE for most import alerts. There is no particular form to complete when petitioning for removal from detention without physical examination. In your petition you should outline the corrective actions and steps taken by the firm to prevent the problem which led the firm to be placed on the import alert.

Individual Import Alerts may include specific information regarding removal from DWPE. You should review the import alert specific to your request and submit any and all documentation called for. You can access FDA's Import Alerts at the following link: http://www.accessdata.fda.gov/cms_ia/ialist.html.

For most import alerts, you are also expected to supply information relating to a minimum of five entries shipped to the U.S. and subsequently analyzed or examined and found to no longer be in violation. Submit the following documents for each entry you supply in support of your petition.

  • Invoice

  • Packing List

  • Bill of Lading

  • US Customs Form 3461 or US Customs Form 7501 (Required for manual/paper entries only)

*Please note you do not need to submit the actual private laboratory results with your removal petition.

You may e-mail a removal petition to FDA’s Division of Import Operations (DIO) at importalerts2@fda.hhs.gov or mail to:

FDA
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

 

Though not mandatory, you should include the following information in a coversheet to help expedite the review of your petition:

  • Statement requesting the importer/manufacturer/shipper/product to be removed from the red list or added to the green list of an Import Alert;

  • Provide Import Alert number;

  • Provide name and address of the manufacturer or grower;

  • List the entry numbers of released shipments.

Back to top

Will DIO notify me when they receive my removal petition?

Yes, you will receive an acknowledgement in the form in which you sent the petition (mail or e-mail), which includes the case number and an FDA contact person including their phone number and e-mail.

Back to top

What is DIO's process for reviewing removal petitions?

  • Petitions are reviewed on a first in-first out basis.

  • Reviews can take 30 days to process and the turnaround time may fluctuate.

  • FDA will send a letter when a decision is made.

  • Denial letters will include an explanation or reason for denial.

  • Approval letters will include the FDA notice to field offices.

  • Approvals are effective immediately.

  • Decision letters close the case.

Back to top

What are some common reasons for denial of a removal petition?

  • Failure to submit steps the firm has taken to correct the violations.

  • Failure to submit entry documentation which demonstrates manufacturer information/shipping history.

  • Failure to submit other information as required by the import alert.

  • Product failures.

  • Staging shipments:

    • Breaking up large shipments into smaller ones to count as more than one.

    • Shipping small quantities of product as opposed to historical size.

Back to top