FDA Warning Letter to Jeni’s Splendid Ice Creams over Listeria Contamination in Production Facility

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

The Food and Drug Administration (FDA) has sent a warning letter to Jeni’s Splendid Ice Creams after finding listeria bacteria in the company’s Columbus, Ohio manufacturing facility in January.

In a letter dated August 9, 2016, the FDA says it found Listeria monocytogenes (L. monocytogenes) in the facility. Two positive samples were found near where the company was manufacturing the base for its Intelligentsia Black Cat Espresso ice cream. According to the letter, the FDA collected 75 samples on January 26, 2016. Two samples tested positive for L. monocytogenes. The samples were taken from the floor of the prep room adjacent to the open entryway to the dish room and approximately nine feet from the prep table where the Black Cat Espresso ice cream base was being prepared. Samples also came from the floor of the wash room around a drain about two feet from a sink used to wash, rinse, and sanitize equipment parts, utensils, and containers used in production, and approximately three feet from shelves where those items are stored.

The letter said FDA investigators observed violations of Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulation. The FDA determined that “your frozen flavor base products are 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 they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”

This is not the first time Jeni’s Splendid Ice Creams has been cited for listeria in its production facility, WCMH-TV in Columbus reports. The company issued a recall in 2015 and closed ice cream shops after listeria contamination was found in the production facility. Without proper controls, the FDA letter says, the bacteria “can proliferate in food processing facilities where it may contaminate food. Consuming this contaminated food can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern.”

The FDA said the evidence from the 2016 inspection indicates that demonstrates that L. monocytogenes “has maintained its presence within your production facility since 2015.” These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.

As with any FDA warning letter, the company fifteen (15) working days from receipt of the letter to respond in writing. Jeni’s must “outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again.” The company must document the corrective actions taken. If the corrective actions cannot be completed within 15 days, or will occur over time, the company must state the reason for the delay and include a timetable for the corrective actions.