August 18, 2019

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FDA Releases Report on Inspection and Environmental Sampling of Ice Cream Production Facilities for Harmful Bacteria

  • A large number of pathogen-related recalls of ice cream (16 over the three-year period of 2013, 2014, and 2015) and a deadly outbreak of listeriosis in 2015 that was linked to ice cream from Blue Bell Creameries (reported here), spurred a special assignment by the Food and Drug Administration (FDA).  Specifically, FDA conducted inspections and environmental sampling of 89 of the nation’s largest ice cream production facilities in 32 states from September 12, 2016, to August 30, 2017.

  • On April 24, 2019, FDA announced the release of its report on the inspection and environmental sampling of about 16% of the domestic ice cream manufacturers in fiscal year 2017/2017 for Salmonella and Listeria monocytogenes.  FDA’s activity began about a month before larger food facilities were required to comply with the Preventive Controls for Human Food Rule that was established by the Food Safety Modernization Act (FSMA).  No objectionable conditions or practices were found at 44 of the 89 inspected plants.  Listeria monocytogenes was detected on non-food contact surfaces in 19 plants and from a food contact surface at 1 plant.  Salmonellawas less prevalent, reportedly detected only from a non-food contact surface and only in one facility.

  • FDA suspended Food Facility Registration for one of the inspected plants, Working Cow Homemade, Inc., after it was linked to a clinical listeriosis case.  After ceasing operations, the firm later resumed business as a warehouse distributor of ice cream products with no production operations.  FDA worked with two other firms to conduct voluntary recalls, held seven regulatory meetings, and notified management at 39 facilities of the need to take voluntary corrective actions.  FDA is also conducting follow-up inspections at all six of the facilities where objectionable conditions or practices warranting official action were observed in the first inspection.

  • FDA’s findings underscore the need for ice cream production plants and other food production facilities to develop and implement a food safety plan.  Please email us at fooddrug@khlaw.com with any questions regarding the Preventive Controls for Human Food Rule or other FSMA requirements.

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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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