FDA import alerts and DWPE: red list, green list and how to get removed

An FDA import alert tells FDA staff that shipments from certain firms, products or countries can be detained without physical examination (DWPE) because they appear to violate US law. A firm on the red list must show the problem is fixed, usually through a petition with evidence, before its goods enter normally again; firms on the green list are exempt from DWPE.

Checked against official sources: 2026-10

At a glance

DWPEDetention without physical examination of shipments covered by an import alert

Red listFirms, products or countries that meet the criteria for DWPE

Yellow listFirms, products or countries under intensified surveillance

Green listFirms, products or countries exempt from DWPE

How firms are listedA violation found at entry, an inspection, historical data or labelling; publication on the alert generally serves as notice

RemovalPetition to importalerts2@fda.hhs.gov following the alert's Guidance section

EvidenceRoutine commercial shipments over a reasonable time and corrective actions; FDA weighs the totality of evidence

QuestionsDivision of Import Operations: fdaimportsinquiry@fda.hhs.gov

How import alerts work

FDA import alerts list firms, products and countries whose shipments can be detained without physical examination. On the red list are those that meet the criteria for DWPE; the yellow list covers those under intensified surveillance or firms that may have resolved GMP issues but still need further exams; the green list covers those that meet the criteria for exemption from DWPE.

A firm can be placed on the red list after a violation found at entry, an inspection, historical data or labelling problems, and it can be listed as the responsible party even if it says it did not export the product. Publication on the alert generally serves as notice. Not every detention comes from an import alert: the Notice of FDA Action states the reason.

Getting removed from the red list

Read the Guidance section of the specific import alert, which explains how to overcome the violation.
Fix the cause and document the corrective action; some alerts require corrective action before shipments can be released.
Show routine commercial shipments over a reasonable time that reflect your normal shipping pattern, not an unusual burst of small shipments.
Send the petition and evidence to importalerts2@fda.hhs.gov; FDA weighs the totality of evidence.
Petitions are not appropriate for products that are temporarily out of production.
If the firm was wrongly listed as manufacturer, shipper or importer, request the records under FOIA and petition with supporting evidence.

Before you ship

Importers should search the import alerts before importing, using several criteria such as manufacturer name, product name and country of origin. Changes in name, ownership, location, equipment, procedures, products or labelling can affect a firm's status, so the firm should tell FDA's Division of Import Operations and send documentation. For a detained shipment, contact the compliance officer named on the Notice of FDA Action; the importer may present testimony and evidence for release.

Step by step

Search FDA's import alerts by manufacturer, product and country before shipping.
If your firm is on a red list, read the alert's Guidance section and fix the cause.
Document corrective actions and build a record of routine, compliant commercial shipments.
Send a petition with the evidence to importalerts2@fda.hhs.gov.
Tell FDA about any change in name, ownership, location, procedures, products or labelling.

Documents you usually need

Notice of FDA Action for detained shipments
Petition for removal with supporting evidence
Records of corrective actions
Records of routine commercial shipments
Laboratory results or other evidence requested by the alert's guidance

Common problems and how to avoid them

Every shipment is detained without examination.

What to do: Check whether the firm or product is on an import alert red list and follow that alert's guidance to petition for removal.

A petition is based on a few small trial shipments.

What to do: FDA looks for routine commercial shipments over a reasonable time that reflect normal shipping patterns.

The firm is listed for a product it says it did not ship.

What to do: Request the records under FOIA and petition with evidence that the listing is wrong.

The factory moved and shipments are still detained.

What to do: Changes in location or ownership can affect status; inform the Division of Import Operations with documentation.

Sources

Industry FAQs for Import Alerts U.S. Food and Drug Administration (FDA)

Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.

Port codes by country

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Trade notes

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Common questions

What is DWPE?

Detention without physical examination: FDA can detain shipments covered by an import alert without sampling them first.

What are the red, yellow and green lists?

Red: subject to DWPE. Yellow: intensified surveillance. Green: exempt from DWPE.

How do I get off an FDA import alert?

Follow the alert's Guidance section, fix the cause and petition importalerts2@fda.hhs.gov with evidence such as corrective actions and routine compliant shipments.

How many clean shipments do I need?

FDA sets no fixed number; shipments should reflect normal commercial patterns over a reasonable time, and FDA weighs the totality of evidence.

Whom do I contact about a detained shipment?

The compliance officer named on the Notice of FDA Action; for import alert policy, the Division of Import Operations.

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