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 . This may seem like a substantial amount, but there are approximately 13,000 companies currently on FDA import alert red lists. 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. 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. Future drug importations from that drug manufacturer will be subject to FDA import detentions and FDA import refusals. Category 3 firms will be listed in the yellow list for this import alert. There are two types of FDA Import Alerts. Approved VQIP Importers. Search Firm Information. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. For example, a company may be on a red list for attempting to 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 Affirmation of Compliance Codes (AofC): The AofCs help the FDA evaluate the import by further defining the import. 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. The FDA validates the s provided against various FDA databases. In this case, FDA notices a pattern of non-compliance from a specific company and adds the company to a red list. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. 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: 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. The most common type is a Red List Import Alert. 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 … 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 …