There is zero tolerance for Listeria monocytogenes bacteria in ready-to-eat products, including deli meats and cheeses and ice cream because the consumer does not heat the food before eating, which would kill the pathogen. Once Listeria is introduced into a facility, it can become persistent and be very difficult to eradicate.
In fact, there have been several issues with Listeria contamination in ice cream plants for the past few years. In April 2019, the FDA stated they were taking steps to improve ice cream production after finding the pathogen in 19 of the 89 ice cream establishments they inspected.
In the Velvet Ice Cream inspection, the FDA found the same strain of Listeria monocytogenes bacteria in the early 2019 inspection that was found during the FDA’s inspection in 2018. Based on the FDA’s inspection and environmental samples, they found that the ice cream manufactured in that facility “is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.”
FDA issued a Form-483, listing deviations from current good manufacturing practices (CGMP) found during the inspection.
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