The FDA has sent a warning letter to the Velvet Ice Cream Company of Utica, Ohio, that Listeria monocytogenes has been found in their facility during inspection. The company makes ready-to-eat ice cream.
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.
Listeriosis, the infection caused by this pathogen, can cause serious illness and death, especially in the elderly, pregnant women, children, and people with compromised immune systems.
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.
Government officials found that the company identified environmental pathogens as a hazard, but did not implement sanitation controls to make sure that the facility minimizes Listeria monocytogenes.
Nine environmental swabs were positive for Listeria. Whole genome sequencing of those swabs identified twenty-one isolates representing six different strains of Listeria monocytogenes. The same strain was found in seven isolates from the 2019 inspection, and eight collected during the 2018 inspection. This indicates that there is a resident pathogen or harborage site in the facility since 2018. And that strain was genetically identical to one clinical isolate from a patient in 2018, which indicates this strain can cause human illness.
The letter also states that the facility did not clean non-food contact surfaces. Inspectors observed overspray from the floor onto equipment, and from the floor onto unopened buckets of ingredients that were used to produce ice cream. The design of the production floor doesn’t allow for proper water drainage (pooling water can be a harborage site for Listeria monocytogenes). The floor was re-sloped, according to the company, but the FDA has not verified this.
The company has 15 working days to respond to the FDA letter.
