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FDA Resumes Inspections of High-Risk Food Facilities

  • As previously reported on this blog, the partial federal government shutdown stalled FDA’s ability to conduct routine inspections of domestic food facilities.  However, as of January 15, FDA resumed inspections of food facilities that produce high risk foods, such as cheeses, other dairy products, seafood, produce, and infant formula, which had been stopped as a result of the federal government shutdown.  These high risk foods account for about one-third of FDA’s 8,400 annual routine inspections. FDA assesses a food or facility’s risk level by examining a number of factors, including the type of food, the manufacturing process, and the compliance history of the facility.

  • During the shutdown, FDA Commissioner Scott Gottlieb has been communicating via Twitter and press interviews. Commissioner Gottlieb noted that, despite the shutdown, FDA has continued all foreign food facility inspections, and will now resume routine inspections of domestic high-risk facilities. However, inspections of low-risk foods, such as baked goods, will not resume at this time. We note that while much of the Agency’s work is funded by industry user fees, inspections of food facilities are covered by taxpayer money and have therefore stalled. As of the time of this blog’s publication, the government has been partially shut down for 26 days.

  • Commissioner Gottlieb’s staff had been calling the furloughed inspectors to see who would or could come back to work, even though they would not be getting paid. According to the Commissioner, approximately 400 unpaid staff are resuming work during the shutdown. Out of the 400, about 150 employees will be focused on food inspections, with the remaining focus on other aspects of FDA’s mission. The Commissioner praised his workforce, stating “[w]e got an overwhelming response from our very dedicated and mission-driven field force who are coming back to work unpaid.”

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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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