Inspectors from the U.S. Food and Drug Administration have again found Listeria at the Jeni’s Splendid Ice Creams manufacturing facility in Columbus, OH. Two of the 75 environmental samples collected there on Jan. 26 were positive for Listeria monocytogenes, according to an Aug. 9 warning letter that FDA posted on Wednesday. The positive samples were taken from the floor of the prep room and the floor of the wash room around a drain, FDA’s letter stated. Analysis using whole-genome sequencing showed it was the same strain of Listeria found in April 2015 at both the Columbus facility and in a finished product sample of ice cream.“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,” according to the letter. “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,” FDA told the company. Jeni’s has been using its Columbus facility to make frozen flavor bases after Listeria was found last year in its production kitchen and in the ice cream sample. Since then, the company has had its finished ice creams produced by Smith Dairy in Orrville, OH. The contamination was initially found in a pint of Jeni’s dark chocolate ice cream randomly tested in Nebraska. The company then halted production, recalled all of its products, and embarked on a thorough cleaning, sanitizing and reconfiguring of its production kitchen that reportedly cost $200,000. Jeni’s also destroyed 265 tons of ice cream worth more than $2.5 million. FDA inspectors who visited Jeni’s production facility in Columbus eight times in April 2015 reported inadequate pathogen controls and cleanliness procedures, which company president and CEO John Lowe indicated at the time had been fixed. Lowe did not respond to a request for comment Wednesday from Food Safety News. However, the company sent out a statement from Mary Kamm, its quality and new product introduction leader, noting that it was the only comment Jeni’s would make about the FDA warning letter. Kamm stressed that a “good Listeria control program” works by constantly searching for the bacteria and then eradicating it before it has a chance to spread to any food contact surfaces. “We believe our final product testing to be the most thorough in the nation,” she said in the statement. “As a result of our sanitation and other food safety procedures, our environmental testing program and our test and hold procedures, we can assure everyone that the food we produce is absolutely 100% safe.” Jeni's ice creamFDA acknowledged in the Aug. 9 warning letter the “extensive corrective actions” the company took last year after the positive Listeria results. Jeni’s hired a sanitation consultant and shut down production to deep clean and sanitize the facility. It also hired a food safety director.

During routine monitoring by the company in June 2015, Listeria was again found in the production facility. Lowe announced May 6, 2015, that Jeni’s had located the “smoking gun” after swab-testing revealed Listeria on the spout of one of its production machines. He also described a new layout for the Columbus production facility to limit cross-contamination and enhance product safety. No illnesses have been reported to date in connection with the consumption of Jeni’s products, according to FDA. Additional problems cited The agency’s Aug. 9 warning letter also pointed out continuing problems with good manufacturing practices at the Columbus plant. FDA inspectors who visited there from Jan. 25 through Feb. 9 observed “a dust-like material” on fan guards and employees pouring sugar so that the outside of the bags came into direct contact with the food contact surfaces of plastic containers.
These were both repeat observations from FDA’s April 2015 inspection, according to the warning letter. In response, Jeni’s told the agency that it had updated cleaning procedures and ingredient transfer practices and completed associated employee training. “We acknowledge these corrective actions and will ascertain the adequacy of your corrective action during our next inspection,” FDA’s letter stated. Infection with Listeria monocytogenes causes listeriosis and can be dangerous to young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, infected pregnant women can suffer miscarriages or stillbirths. In a 2008 industry guidance document, FDA reported that Listeria monocytogenes can survive longer under adverse environmental conditions than can many other vegetative bacteria that present food safety concerns. “In addition to being able to survive and grow at refrigeration temperatures, L. monocytogenes tolerates high salt concentrations, such as in non-chlorinated brine chiller solutions, and survives frozen storage for extended periods,” the document states. “It is more resistant to nitrite and acidity than many other food-borne pathogens. It also is more resistant to heat than many other non-spore forming food-borne pathogens, although it can be killed by heating procedures such as those used to pasteurize milk.” Jeni’s is a medium-sized privately owned firm based in Columbus, OH. Established in 2002 by artist and pastry chef Jeni Britton Bauer, it has about 600 employees working at the company’s main production facility in Columbus or in about 20 scoop shops spread throughout several states and in a selection of major cities. (To sign up for a free subscription to Food Safety News, click here.)