October 22, 2019

October 22, 2019

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October 21, 2019

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FDA Provides Status Report on Recall Rapid-Response Team Activities

  • In April 2016, the Food and Drug Administration established a team of Agency leaders to oversee challenging recalls and to help overcome obstacles and streamline the recall process. Shortly after the team—called SCORE (Strategic Coordinated Oversight of Recall Execution)—was created, we reported on this blog that the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.”

  • Six-months after the creation of the rapid-response team, FDA posted on its blog, FDA Voice, an article about the SCORE team’s activities since its inception, and an interview with the co-chairs of SCORE: William Correll, Director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, Director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA). In the interview, the co-chairs discussed several of the cases that SCORE has been involved with, namely:

    • Suspension of a facility registration because the food there may have been contaminated with Listeria monocytogenes

    • Advising companies that made finished food items with flour containing a peanut protein that the agency would publicize the potential contamination if the company supplying the flour did not implement a voluntary recall within 24 hours

    • Advising a company that made sandwiches distributed in the U.S. Department of Agriculture’s Food Nutrition Service’s school lunch program and where Listeria monocytogenes were found on surfaces where the food was made that the agency would notify the press if a voluntary recall was not initiated within 24 hours

    • Threatened enforcement actions if a company that manufactured infant formula without testing for Cronobacter did not initiate a voluntary recall within 24 hours

  • Under the Food Safety Modernization Act (FSMA), FDA was given mandatory recall authority over conventional foods.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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