Can I still import from a supplier on an FDA red list?

Possibly, but each shipment of the listed product can be detained without physical examination, and release requires evidence such as private laboratory results described in the alert's Guidance section. FDA notes that for some alerts the violation precludes release, which the Guidance section will say.

Are yellow list shipments detained without physical examination?

FDA's pages differ: the main Import Alerts page says yellow and red list firms are subject to DWPE, while the Data Dashboard supplier evaluation page says yellow list firms' products are not detained without physical examination. Check the Guidance section of the specific alert.

How often do import alert lists change?

FDA states that import alert databases are updated in real time, and each list entry shows the date it was published. Alerts are revised whenever FDA adds or removes a firm or product.

Does FDA tell the importer when a supplier is added to a red list?

Generally no. FDA's FAQ says that in most cases publication on the import alert serves as notification, so importers have to watch the alert pages or use a monitoring service.

Guide

Import alert red list vs green list vs yellow list

Updated October 22, 20266 min read7 primary sources

On an FDA import alert, the red list names firms, products or countries that have met the criteria for detention without physical examination (DWPE), the green list names those that have met the criteria for exemption from DWPE under that alert, and the yellow list names those subject to intensified surveillance. Put simply, red-list shipments can be detained without testing, green-list shipments are exempt from that alert's DWPE, and yellow-list shipments face closer scrutiny.

Key facts

Red list: Met the criteria for DWPE under the alert
Green list: Met the criteria for exemption from DWPE under the alert
Yellow list: Subject to intensified surveillance
Notice to firms: In most cases, publication on the alert is the notification
Update speed: FDA says import alert databases are updated in real time

What do the red, green and yellow lists mean?

An import alert tells FDA field staff which products, from which firms or countries, may be detained without physical examination. The lists attached to each alert say who is in scope. FDA's Import Alert FAQ defines them as follows.

FDA's definitions of import alert lists

List	FDA definition	What it means at entry
Red list	Firms, products and/or countries which have met the criteria for Detention without Physical Examination (DWPE) under an import alert	Shipments of the listed products can be detained without sampling; the importer must show they are not violative to get them released
Green list	Firms, products and/or countries that have met criteria for exemption from DWPE under an import alert	The listed firm's products are exempt from that alert's DWPE; products from firms not on the green list remain subject to it
Yellow list	Firms, products and/or countries subject to intensified surveillance, or firms that may have satisfied GMP issues but where the nature of violations may warrant further field examinations or additional analyses	Entries may receive more examinations or analyses; see the note below on DWPE

Why do some import alerts have a green list?

Some import alerts apply to a whole country, area or product type rather than to named firms. Under those alerts, every shipment in scope is subject to DWPE unless the firm has qualified for the green list. FDA's supplier evaluation page explains that green list firms are often associated with an alert because the alert is country-wide or area-wide.

That is why a name search alone is not enough when you check a supplier. A supplier that appears on no red list can still be in scope of a country-wide alert if it is not on that alert's green list. The full method is in How to check if a supplier is on an FDA import alert.

What does it mean when a firm is no longer on a list?

FDA's Import Alert FAQ answers this directly, and the answer is opposite for the two lists:

No longer on the red list: the appearance of the violation has been overcome, and that firm and product are not subject to DWPE under the alert.
No longer on the green list: the appearance of the violation is no longer considered overcome, and that firm and product are subject to DWPE under the alert.

A change in the conditions that FDA relied on can also change a listing. FDA lists examples such as a change in company name, ownership, physical location, equipment, procedures, products or labeling, and asks listed firms to notify the Division of Import Operations of such changes.

Does FDA notify a firm when it is added to a red list?

Usually not individually. FDA's FAQ, citing Regulatory Procedures Manual chapter 9-8, says that in most cases the publication of a firm or product on an import alert, or its removal, serves as notification to the firm. For an importer, that means the first sign of a supplier's listing may be a detained shipment unless someone is watching the alert pages.

This matters for FSVP. A listing is new information about a supplier's compliance, and 21 CFR 1.505(c)(1) requires a prompt reevaluation when you become aware of it. See When to reevaluate a foreign supplier under FSVP.

How do you read a firm entry on an import alert list?

Red list entries are grouped by country. Each entry gives the firm name, a Date Published, the address, and one or more product lines. Each product line has an FDA product code, its description, its own Date Published, and sometimes a description or note.

FDA product codes combine an industry code, class code, subclass, process indicator code (PIC) and group code. Subclass and PIC are often shown as dashes. For example, a line reading 16 J - - 05 Shrimp & Prawns has industry code 16 (fishery and seafood products), class J and group 05. FDA's Product Code Builder decodes any code.

The listing covers the products named, not necessarily everything the firm makes. Two examples you can read on SupplierRadar: Import Alert 16-129 (seafood, nitrofurans) and Import Alert 99-19 (food products, Salmonella).

How do firms get onto and off a red or green list?

FDA adds firms to a red list based on evidence such as violative samples, inspection findings or a pattern of violative entries, following its Regulatory Procedures Manual. A firm leaves the red list, or joins a green list, by petitioning FDA with evidence. FDA's removal page describes the elements:

What a petition typically covers (FDA removal page)

Request	What FDA asks the petition to show
Remove from red list	Investigation (how the problem occurred), corrective actions, preventive measures, and evidence such as 5 clean shipments or a third-party audit
Add to green list	Analysis (whether the problem exists in the product), preventive measures, and evidence such as 5 clean shipments or a third-party audit

The step-by-step process is in How to get off an FDA import alert.

Frequently asked questions

Can I still import from a supplier on an FDA red list?: Possibly, but each shipment of the listed product can be detained without physical examination, and release requires evidence such as private laboratory results described in the alert's Guidance section. FDA notes that for some alerts the violation precludes release, which the Guidance section will say.
Is a green list firm approved by FDA?: A green list entry means only that the firm's listed products have met the criteria for exemption from DWPE under that one alert. It is not a general FDA approval or certification of the firm.
Are yellow list shipments detained without physical examination?: FDA's pages differ: the main Import Alerts page says yellow and red list firms are subject to DWPE, while the Data Dashboard supplier evaluation page says yellow list firms' products are not detained without physical examination. Check the Guidance section of the specific alert.
How often do import alert lists change?: FDA states that import alert databases are updated in real time, and each list entry shows the date it was published. Alerts are revised whenever FDA adds or removes a firm or product.
Does FDA tell the importer when a supplier is added to a red list?: Generally no. FDA's FAQ says that in most cases publication on the import alert serves as notification, so importers have to watch the alert pages or use a monitoring service.

Sources

Every legal and FDA-process claim above is cited to a primary source. Access dates show when each page was read.

01FDA: Industry FAQs for Import AlertsFDA · accessed October 22, 2026
02FDA: Import AlertsFDA · accessed October 22, 2026
03FDA Data Dashboard: Firm/Supplier Evaluation ResourcesFDA · accessed October 22, 2026
04FDA: Removal from DWPE Under Import AlertFDA · accessed October 22, 2026
05FDA Import Alert 16-129FDA · accessed October 22, 2026
06FDA Regulatory Procedures Manual, Chapter 9 (March 2024)FDA · accessed October 22, 2026
0721 CFR 1.505 (eCFR)eCFR · accessed October 22, 2026

Put it into practice

Know when a supplier moves on or off a list

Watch a supplier and SupplierRadar emails you when its import alert status changes, including a red list addition or a green list removal, with a link to the FDA alert page. Your first supplier is free.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.