Overview

This page provides an overview of the FDA’s procedures for removing a product and/or firm from Detention Without Physical Examination (DWPE) status, or from import alert.

• How do I get a product and/or firm removed from the red list or added to the green list of an import alert (removed from DWPE)?

• How do I submit a request for removal from an import alert (removed from DWPE)?

• How will I know the FDA received my petition for removal from DWPE?

• How will I know if my petition has satisfied the criteria for removal from DWPE?

• What are some common reasons a petition for removal from DWPE is denied?

How do I get a product and/or firm removed from the red list or added to the green list of an import alert (removed from DWPE)?

The FDA must have evidence that the conditions that gave rise to the apparent violation have been resolved and that the FDA has confidence future entries will be in compliance with FDA laws and regulations.  This evidence will differ depending upon the nature of the violation and evidence supporting DWPE for the firm and/or product.

General requirements for removal from DWPE can be found in the FDA’s Regulatory Procedure Manual, Chapter 9, Subchapter: Detention Without Physical Examination (DWPE). Additionally, the “Guidance” section within an import alert may provide specific requirements and contact information.  

The FDA may require a root cause analysis to determine the source of the violation, a description of the corrective actions taken, and/or preventative measures put in place to prevent the violation from occurring in the future.

Supporting evidence can vary by violation and import alert. Supporting evidence may include, but is not limited to:

• Third-party laboratory analyses
• Manufacturing or processing records
• FDA establishment inspections
• Proof of registration and/or listing
• Proof of certification by a foreign government or certified body
• Evidence that labeling violations have been corrected
• Evidence that the product is in compliance

Requests for removal from the red list or addition to the green list can be submitted via a petition to the FDA’s Division of Import Operations (DIO).

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How do I submit a request for removal from an import alert (removed from DWPE)?

Once you have determined what information you will need to present, you may submit a petition to the FDA’s Division of Import Operations (DIO). There is no form to complete when petitioning for removal from DWPE. To avoid delays, consider including the following:

• Cover letter
  • Statement requesting the firm/product to be removed from DWPE
  • Import alert number
    • Please submit a separate petition for each import alert the product and/or firm appears on (i.e., one petition per import alert).
  • Name and address of the firm petitioning for removal from DWPE
  • List the entry numbers of released shipments (if applicable)
• Supporting evidence
  • May include root cause analysis, description of corrective actions, description of preventative measures, proof of registration or listing, third-party laboratory analyses, third-party audits, copies of product labeling, certificates of analysis, etc.
    • Note: Third-party lab analysis packages that were previously provided to the FDA via ITACS do not need to be submitted with the petition.
  • Attach each piece of evidence as a separate PDF file with a descriptive document title.
• Letter of authorization (if applicable)
  • A letter of authorization should be included if you are submitting the petition on behalf of a firm listed on import alert. The letter should be on their company letterhead, signed, dated, and stating the capacity in which you may represent the firm.

Petitions can be emailed to the FDA’s Division of Import Operations (DIO) at [email protected] or sent by mail to: 

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

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How will I know the FDA received my petition for removal from DWPE?

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

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How will I know if my petition has satisfied the criteria for removal from DWPE?

Petitions are reviewed on a first in, first out basis. The timeframe for a petition to be reviewed will vary on complexity and completeness of the case. Once the review is complete, you will receive a letter indicating whether your petition has met the criteria for removal from DWPE.

• If the criteria have been met, the letter will indicate the removal from DWPE.

• If the criteria have not been met, the letter will indicate the reasons that your request did not meet the criteria for removal.

Once the letter is issued, the case is considered closed. For subsequent requests, a new petition can be submitted to [email protected]. Do not submit new petitions to previous case reviewers. 

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What are some common reasons a petition for removal from DWPE is denied?

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

• Failure to present information that would give the FDA confidence that future shipments would be in compliance

• Failure to submit entry documentation for five (5) consecutive, compliant shipments

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

• Reoccurrence of the violation

• 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

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