Import Alerts - Red & Green Lists
FDAeasy.com can assist you to submit a petition to DIO (Division of Import Operations) for removal from DWPE for most import alerts. There is no particular form to complete when petitioning for removal from detention without physical examination. We can outline the corrective actions and steps to prevent the problem which led your firm to be placed on the import alert.
Individual Import Alerts may include specific information regarding removal from DWPE. You should review the import alert specific to your request and submit any and all documentation called for. Don’t hesitate to be assisted by FDAeasy.com.
Red, Green and Yellow Lists
Red List: Firms, products and/or countries are subject to DWPE under the Import Alert.
Green List: Firms, products and/or countries that have met criteria for exemption from DWPE under the Import Alert.
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 of individual entries and/or additional analyses.
If your product is detained without physical examination, you have the right to provide evidence to FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States.
Removing products from DWPE
In order for FDA to consider removing a product and/or firm from DWPE, FDA must have evidence that the conditions that gave rise to the apparent violation have been resolved and that gives FDA confidence future entries will be in compliance with FDA laws and regulations.
Import alerts inform FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. Before importing into the United States, importers should know if their products are subject to DWPE. DWPE allows the agency to detain a product without physically examining it at the time of entry.