FDA Import Alert & Detention Assistance — Get Connected Now
DWPE, Import Alert & Refusal — Expert help fast. Don't miss your respond-by date.
Your Notice of FDA Action lists a respond-by date. If FDA doesn't receive a response by then, the compliance officer may issue a refusal of admission. The respond-by date is typically 10 business days (up to 20 calendar days).
- Notice of FDA Action (Detained)
- DWPE / Import Alert
- Refusal of Admission
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What is an FDA shipment detention / Notice of FDA Action?
When FDA detains a shipment at the border, the agency issues a Notice of FDA Action (detention notice). The notice states the reason for detention and a respond-by date. You must respond before that date or the shipment may be refused admission.
Get help responding →Detention & Hearing: what to do before the respond-by date
Submit a written response to FDA by the respond-by date. Include evidence or corrective actions that address the violation cited. If you need more time, request an extension in writing before the date. Missing the date can lead to refusal of admission.
Get matched for detention response →DWPE & Import Alerts (Red List): evidence typically needed for removal
Detention Without Physical Examination (DWPE) under an Import Alert means future shipments can be detained without examination until the firm is removed from the alert. Removal usually requires submitting evidence of corrective actions, updated procedures, or third-party audits. FDA reviews and decides.
Get matched for DWPE removal →Refusal of Admission: what it means and what options exist
If FDA refuses admission, the shipment cannot enter the U.S. for consumption. Options typically include export, destruction, or in some cases reconditioning (Form FDA 766). An import compliance expert can outline options and next steps.
Get help with a refusal →Reconditioning & relabeling: when Form FDA 766 applies
Form FDA 766 (Application for Authorization to Recondition) is used when you want to bring a detained or refused shipment into compliance (e.g. relabeling, reconditioning) instead of exporting or destroying it. FDA must approve the application.
Get help with FDA 766 →How our matching works
- You submit the form above. We triage within 1 business day.
- We match you with 1–3 vetted providers (consultants, labs, or attorneys) based on product type and situation.
- You speak with them directly. We are a marketplace; we do not provide legal advice.
Documents checklist
- Notice of FDA Action (detention notice)
- Entry number / CBP reference
- Product description and intended use
- Any corrective action or evidence you already have
Frequently asked questions
How long do I have to respond to a Notice of FDA Action?
The Notice of FDA Action includes a specific "respond-by" date. If FDA does not receive a response by that date, the compliance officer may issue a refusal of admission.
What is the "respond-by" date usually?
FDA notes the respond-by date is typically 10 business days, but can be up to 20 calendar days to allow for weekends, holidays, and mailing time. Always follow the date on your notice.
Is every detention due to an Import Alert?
No. Some detentions are one-time holds (e.g., missing documentation or labeling issues). An Import Alert/DWPE means future shipments may be detained without physical examination until the firm is removed.
What should my detention response include?
A written response addressing each cited issue, with supporting evidence such as records, corrective actions, test results, and documentation relevant to the reason for detention.
Can I request an extension?
In some cases you can request an extension in writing before the respond-by date, with a clear reason and plan.
How do I get removed from DWPE / an Import Alert red list?
Removal typically requires evidence that the underlying issue has been corrected and controls are sustained (e.g., corrective actions, updated procedures, audits). FDA reviews and decides.
What is Form FDA 766 and when is it used?
Form FDA 766 is an application requesting authorization to relabel or recondition certain non-compliant imported products to bring them into compliance, rather than exporting or destroying them.
What happens after a refusal of admission?
A refused shipment generally cannot enter U.S. commerce. Options often include export or destruction, and in some cases approved reconditioning.
How fast can you match me to someone?
We triage quickly and match you to 1–3 providers based on product type and urgency.
This page is for informational purposes only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not a law firm and do not provide legal advice. We match you with vetted providers who may assist with import compliance. See our Privacy Policy for how we share data with matched providers.