Each colour coded Import Alert list indicates the level of scrutiny with which the FDA monitors products, manufacturers and shippers on the Import Alert list. AofC If accurate A of C’s are provided the entry may pass the new system auto look-up and may be “May Proceeded” by the system. According to U.S. Food and Drug Administration (FDA) records obtained by Registrar Corp through a Freedom of Information Act request on October 20, 2014, FDA received approximately 368 petitions to be removed from an import alert red list in 2013. For example, a company may be on a red list for attempting to import … This may seem like a substantial amount, but there are approximately 13,000 companies currently on FDA import alert red lists. Approved VQIP Importers. This results in FDA blocking and automatically detaining imported drug shipments from that drug manufacturer until the drug GMP compliance problems are solved (and documented for FDA … The data used to generate the dashboard graphs and search results are based upon data already available to the public through the FDA.gov website. In this case, FDA notices a pattern of non-compliance from a specific company and adds the company to a red list. The FDA validates the s provided against various FDA databases. The most common type is a Red List Import Alert. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Because as customs brokers we want you to be prepared and, thus, presented you with the worst-case scenario, most of what we described in the last section would apply to the red list . There are two types of FDA Import Alerts. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Search Firm Information. The purpose of the Green List is to alert the field to the names of the Category 3 firms certified by SENASICA for which the FDA … Future drug importations from that drug manufacturer will be subject to FDA import detentions and FDA import refusals. View importers participating in Voluntary Qualified Importer Program (VQIP). Search the FDA firm and supplier database, which includes the following: compliance information, recalls, import alerts and refusals where applicable. Category 3 firms will be listed in the yellow list for this import alert. The datasets and data include the Inspections Database, Recalls, Import Alerts and selected data elements from the compliance and enforcement related information on FDA.gov. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA FDA Import Office Locations and Contact Information: Import Alerts: Import Refusals: Access FDA Product Code Query: For technical assistance please contact (itacssupport@fda.hhs.gov) Log In or Request an ITACS Account: Affirmation of Compliance Codes (AofC): The AofCs help the FDA evaluate the import by further defining the import. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA