How to get a firm removed from an FDA import alert (red list)

What FDA asks for

FDA's Regulatory Procedures Manual (Chapter 9-8, 'Detention Without Physical Examination') sets the framework: to be removed, a firm must give FDA evidence that the conditions that led to the violation have been resolved, so the agency has confidence future shipments will comply with the Federal Food, Drug, and Cosmetic Act.

For most adulteration-based alerts, the practical core of that evidence is a track record of clean entries: as a general guideline FDA looks for a minimum of five consecutive non-violative commercial shipments, with the detentions resolved through private laboratory analysis, before it will consider a removal petition. Depending on the alert, FDA may also want documentation of the corrective actions at the facility (HACCP changes, water treatment, supplier controls, third-party audits).

The petition itself

Removal requests are submitted in writing to FDA (currently via email to the import alert petition inbox listed on each alert page, e.g. Importalerts2@fda.hhs.gov), with all supporting evidence attached: entry numbers of the clean shipments, laboratory reports from the private labs, and the corrective-action documentation. FDA may collect and analyze audit samples before deciding.

There is no statutory deadline for FDA to decide. In practice petitions take months; incomplete petitions take longer because the clock effectively restarts when FDA asks for missing evidence.

Green lists: the other exit

For countrywide alerts (where a whole country's product is subject to DWPE by default), the goal is different: getting ONTO the green list — the published list of firms that have met FDA's criteria for exclusion from detention. The evidence bar is similar, and the result is published on the same alert page.

While you work on removal

Every shipment you send while listed will likely be detained, and each detention must be individually resolved with private lab evidence — those same resolutions are the raw material for the removal petition. Track them carefully: entry numbers, sample results, dates.

Monitor the alert page itself: FDA publishes removals with a date, and your customers' compliance teams often see the listing before you do. Import Alert Radar can watch your own firm and notify you the day your listing changes.

Get help

If you have received a DWPE notice or found your firm on a red list, the intake form on our home page routes to people who deal with this weekly. This guide is informational only — it is not legal advice, and every alert has its own removal criteria published on the official FDA page.