Red List Removal and Import Alerts

Services are offered globally to international food and dietary supplement companies.

GFSS has over 10 years of experience working with food and dietary supplement companies that have been placed on the FDA Red List or FDA Import Alert. The FDA adds companies to the Red List when it has sufficient evidence that a product from that company may violate FDA regulations for misbranding, adulteration, failure to meet regulatory standards, and other public health concerns that cause the product to be potentially unsafe for US consumption. The identified products and manufacturers are subjected to increased FDA surveillance because of potential FDA regulatory violations.  There are several different kinds of FDA Import Alerts including the Red List and Detention Without Physical Examination (DWPE).

Removing your company from the FDA Red List or other Import Alert can be a lengthy process and involve considerable effort from your company.  Navigating through the process of FDA Red List and DWPE removal can be very stressful and costly for an international company. 

GFSS will assist you and be your FDA liaison throughout the process of taking corrective actions and submitting documentation to get and keep your company off the FDA Red List.

GFSS offers the following services:

• Petition the FDA on your behalf for DWPE and Red List removal
• Prepare a corrective action plan and appropriate response to FDA violations
• Act as your liaison between your company and the FDA
• Provide expert, technical food or dietary supplement consultation to your company to ensure your company is not placed on FDA DWPE or the Red List in the future