Firms/products/importers become subject to DWPE when there is evidence of a violation(s) of the FD&C Act. For the FDA to remove a product or firm from DWPE, there must be evidence that the conditions that led to DWPE have been resolved and that future shipments of the product will be safe and compliant. This evidence will differ depending upon the nature of the violation and evidence supporting DWPE for the firm and/or product.
The FDA’s Regulatory Procedures Manual (RPM) Chapter 9-8 outlines situations in which a product/firm/country may be subjected to DWPE and general considerations for removal. Additionally, the “Guidance” section of the applicable import alert(s) may contain important instructions and contact information for requesting removal from DWPE.
The FDA will consider the totality of evidence presented for removal from DWPE. Your petition may contain different elements and types of evidence depending on the import alert, product, problem, and type of removal (remove from red, add to green). This table is meant to help you decide what type of documentation you might consider providing.
| Red List |
|---|
| Investigation (How did this problem occur in my product?) |
| Corrective Actions (What did I do to fix it?) |
| Preventive Measures (What did I do to ensure it won’t happen again in the future?) |
| Evidence (e.g., 5 clean shipments, third-party audit, etc.) (How can I show FDA that my corrective actions and preventive measures are preventing the problem from re-occurring?) |
| Green List |
|---|
| Analysis (Does this problem exist in my product?) |
| Preventive Measures (What do we do to ensure this problem does not occur in our product?) |
| Evidence (e.g., 5 clean shipments, third-party audit, etc.) (How can I show FDA that my preventive measures are preventing the problem from occurring? |
Where to email Petitions: [email protected] (there are certain exceptions where petitions go directly to the Division CO, which would be stated in the “Guidance” Section of such import alert).
Questions about DWPE, Import Alerts, or Petitions: [email protected]