FDA Import Alert Explained: DWPE, Red/Yellow/Green Lists and Import Alert 66-40

Short answer: an FDA import alert is a notice that FDA uses to protect consumers against products with a history of known violations. For listed firms and products it allows detention without physical examination (DWPE): the shipment is detained and refused unless the importer shows FDA that the violation does not exist. Import alert 66-40, for example, covers drugs from firms that have not met drug GMPs, not medical devices. This is general regulatory information, not legal or medical advice.

Definition and scope

FDA’s Import Alerts page says alerts inform the public, the import community and FDA staff about products with a history of known violations. FDA can place a product on an alert after finding a violation, and the violation may relate to the product, the manufacturer, the shipper, the importer or the country of origin. Alerts are published in FDA’s online import alert database, which the agency describes as updated in real time (FDA page content current as of 03/03/2025).

An alert is not a warning letter and not an inspection form. A warning letter and an inspection observation record (FDA Form 483) are separate enforcement documents; an import alert is the tool that acts on shipments at the border.

What does detention without physical examination mean?

FDA’s term is “detention without physical exam” (DWPE). Under an alert that uses DWPE, a listed product is detained and refused entry unless the importer shows FDA that the violation does not exist. The burden therefore sits with the importer rather than with the agency. Where a shipment is refused admission, 21 CFR 1.94 provides a hearing: the division director gives written or electronic notice of “a place and a period of time” for the owner or consignee to present testimony, which can be changed on timely request giving reasonable grounds. If an application for relabeling or other action has not been filed at or before the hearing, the director sets a reasonable deadline for it (21 CFR 1.94(b)).

For the wider entry process, including what FDA checks when a device is offered for import, see the guide to importing medical devices into the US; this page does not repeat it.

Red, yellow and green lists

Each alert lists firms and products by colour. The same colour means different things for the shipment, so read the list before the title.

Where the firm or product appears	Effect under that alert	Source
Red list or yellow list	Subject to DWPE under that alert	FDA Import Alerts page
Green list	Exempt from DWPE under that alert	FDA Import Alerts page
Not on the green list	Subject to DWPE under that alert	FDA Import Alerts page

The exemption applies only to the alert in question. A green-list position under one alert says nothing about another.

What is import alert 66-40?

Import alert 66-40 is titled “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs” and its type is DWPE (FDA import alert 66-40). It concerns human and animal drugs, which FDA’s drug and veterinary centers review. Detention may be appropriate when a firm is “not operating in conformity with current good manufacturing practice requirements (CGMP)”. FDA divisions may detain listed drugs from red-list firms without physical examination. For background on the underlying standard see GMP vs cGMP.

The alert also states that personal importation follows chapter 9-2 of FDA’s Regulatory Procedures Manual, and that commercial or promotional shipments generally do not qualify for enforcement discretion.

How a firm is removed

Each alert has a guidance section on how to be removed. Under 66-40 the pieces fit together as follows.

Goal	What alert 66-40 says is needed
Release of a detained shipment	Documentation to the division compliance office showing that the violations were corrected
Removal from the red list	Evidence that the manufacturer resolved the conditions that led to listing
When other enforcement actions are involved	FDA generally inspects first

Source: FDA import alert 66-40.

Where it matters for labs, clinics and supply decisions

A buyer does not appear on an alert; the manufacturer, shipper, importer, product or country of origin does. Three practical readings follow from the sources above.

• Check the alert’s scope. Alert 66-40 is a drug alert. Finding “66-40” on a supplier record is not a device finding, and assuming it applies to devices is a misreading to avoid.
• Check the list colour. A supplier on a red or yellow list is subject to DWPE, which means detained shipments for that product under that alert.
• Know who carries the burden. The importer must show FDA that the violation does not exist.

Common misunderstandings

• “An alert means the product is banned.” FDA describes DWPE as detention and refusal unless the importer shows the violation does not exist, and each alert has a removal route.
• “Green list means FDA-approved.” Green-list status means exempt from DWPE under that one alert, nothing more.
• “A warning letter and an import alert are the same.” They are separate FDA tools; see the warning letter guide linked above.

FAQ

What is import alert 66-40?

It is FDA’s detention without physical examination alert for drugs from firms that have not met drug GMPs. It is not a device alert; see the section above.

What are the requirements for FDA medical device importer registration?

Establishment registration and device listing are the basic FDA requirements for device firms, and who must register depends on the firm’s role. The guide to importing medical devices into the US sets out who must register and the sources. Registration status is separate from import alert status: an alert concerns a specific firm and product.

How to check if something is FDA cleared?

For a 510(k)-cleared device, FDA publishes 510(k) records in its openFDA device 510(k) endpoint (searchable by fields such as product code). openFDA states that results are unvalidated and should not be used for medical-care decisions. Clearance is a premarket question and an import alert is a firm and product enforcement question, so one does not answer the other; the 510(k) guide explains the pathway.

Sources

All sources checked 2026-10-31.

• FDA, Import Alerts: https://www.fda.gov/industry/actions-enforcement/import-alerts (content current as of 03/03/2025).
• FDA, Import Alert 66-40, “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs”: https://www.accessdata.fda.gov/cms_ia/importalert_189.html
• 21 CFR 1.94, Hearing on refusal of admission: https://www.law.cornell.edu/cfr/text/21/1.94
• FDA, openFDA device 510(k) API: https://api.fda.gov/device/510k.json