August 9, 2016: Jeni’s Splendid Ice Creams Receives FDA Warning Letter

Jeni’s Splendid Ice Creams FDA Warning Letter News – The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Jeni’s Splendid Ice Creams on August 9, 2016, stating that environmental testing detected the presence of the foodborne pathogen, Listeria monocytogenes, at the company’s frozen flavor base manufacturing facility. The facility, located at 909 Michigan Avenue, Columbus, Ohio, was inspected on January 25, 2016 through February 9, 2016.

The Warning Letter indicates that 2 of 75 environmental samples collected from the facility on January 25, 2016, tested positive for Listeria. The postive samples were obtained from a floor adjacent to areas where food was processed and packaged; and from a wash room drain located 2 feet from a sink used to wash, rinse, and sanitize production equipment, and 3 feet from shelving were cleaned production equipment is stored.

Jeni’s Splendid Ice Creams Facility Tests Positive For Listeria in 2015 and 2016 – Same Strain Detected

FDA inspectors previously detected Listeria at the Jeni’s facility during an inspection in April 2015, and in a finished Jeni’s ice cream product sample that was also collected in April 2015. A recall for Jeni’s ice creams was initiated on April 23, 2015. Currently, Whole Genome Sequencing (WGS) analysis has provided DNA evidence that the Listeria isolated during January 25, 2016 testing is identical to the strain of Listeria that was isolated from the facility and finished ice cream product in April 2015.

The FDA concluded that Listeria has not been eradicated from the facility since its previous inspection stating “The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015. The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility.”

The agency is requiring the company to take corrective measures to eradciate the potenitally fatal bacterial pathogen from the facility. “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.”

CGMp Violations Noted

Current Good Manufacturing Practices(cGMP) violations related to the contamination of food-contact surfaces and production procedures that may contribute to contamination were also noted in the FDA Warning Letter. The FDA noted corrective actions taken by the company and indicated that the effectiveness of these steps would be evaluated during the next inspection.

The company is required to respond in writing to the FDA within fifteen (15) working days from receiving the Warning Letter with an outline of specific corrective steps and documentation of corrective actions. The company is required to complete these measures within 15 days, or to provide a timetable for completion.

About Listeria

Please see Listeria and Listeria Symptoms to learn more about Listeria food poisoning.

According to the FDA, “L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or the equipment. Without proper controls, it 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, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.”

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