CORE Investigation Process
CORE includes a Signals and Surveillance Team, three Response Teams, and a Post-Response Team. An investigation coordinated by CORE begins with the Signals and Surveillance Team.
The Signals and Surveillance Team is all about early detection that will limit or prevent illness linked to dietary supplements, cosmetics, and foods for both people and animals regulated by the FDA. Team members comb through information that is reported into various databases by local and state health agencies and even search through news stories. The team members are looking for “signals” or “red flags” that could be an early warning of a pending outbreak. They discuss emerging disease surveillance trends directly with CDC and, through FDA field offices, with state health agencies. In addition, the Signals Team searches FDA data for historical information on firms, such as past inspections or sampling results, all in an effort to “connect the dots.”
Once an outbreak related to an FDA-regulated product is identified, all of the available information is handed over to one of the three response teams. Response Teams have one goal: to control and stop the outbreak. First, they must find the source and then they must ensure contaminated product is taken out of circulation. To do that, a Response Team works directly with the FDA field offices and their investigators on a response strategy. In a combined effort, the team, field offices and state and local agencies track down leads, and trace product distribution. The information provided through this detective work is evaluated against the information on illnesses to make sure the investigators are on the right track. Close coordination among the FDA, CDC, and state and local regulatory, public health and agriculture departments is crucial to stopping an outbreak. CORE is the coordination point for all FDA resources.