April 12, 2024

FDA 483 Report on Jeni’s Splendid Ice Creams

The FDA has released Form 483 about their inspection of Jeni’s Splendid Ice Creams facility in Columbus, Ohio. That firm recalled all of their products in April 2015 because Listeria monocytogenes was found in the ice cream.

FDAlogoThe report states that the Regulatory manager and the Director of Operations, who are responsible for assuring compliance with current good manufacturing practices to all personnel, demonstrated a lack of competency. The observations follow.

They did not have an environmental sampling and testing program in place. Neither the Regulatory Manager nor the Director of Operations were aware that “employees on the p.m. shift were not sanitizing the food contact surfaces of the inside of the batch freezers at the end of the production day.” Towels which were being used as sanitizing wipes on food surfaces and thermometers did not actually contain any sanitizer.

No one applied sanitizer or disinfectant to the floors of the facility. Spilled ice cream base mix was found on the floor in the large walk-in cooler. There are no door foamers, sanitizing mats in three doorways to protect the floors of the manufacturing areas from cross-contamination from foot traffic. And aprons and chef coats were hung so they were in direct contact with the prep room floor.

On 4/21/15, during the manufacture of various batches of base mix for Dark Chocolate ice cream, a dark brown residue was seen adhering to the underside of the power outlet box, directly above two prep tables where employees prepare ingredients. Spots of a dark brown residue were on plastic light covers over two ceiling lights over the two prep mix tables. Dust and dirt adhered to the cap and wire on the fire sprinkler directly above the kettle used to prepare base mix. There was also light brown material on the hose reel through which water hose retracts above batch freezers. And discolored vertical strip curtains were in the doorway leading from the large walk-in cooler to the prep room.

There was no cleaning step between preparing batches of base mix in a kettle. There was no cleaning step to remove residual product from the inside of the kettle. And the outside of the paper bag holding cocoa powder cant into direct contact with the inner food contact surface of the kettle.

And the Regulatory Manager and Director of Operations allowed employees to garden in the yard in front of the plant with no controls or procedures to prevent contamination when employees returned to work. Listeria monocytogenes bacteria is ubiquitous in soil.

The facility failed to perform microbial testing where necessary to identify sanitation failures and possible food contamination. They also failed to provide sufficient space for placement of equipment necessary for the maintenance of sanitary operations. There was insufficient space in the plant to maintain an adequate flow of employees and equipment. Employees bumped into each other in the ice cream production room while working.

Listeria monocytogenes bacteria is ubiquitous in the environment. It is found in soil and water and in the digestive tract of some animals, especially poultry and cattle. It is also found in human and animal species. Any manufacturer of ready-to-eat products must be vigilant to prevent contamination of their product by this pathogenic bacteria. Once Listeria gets into a facility, it is very difficult to eradicate. Listeria can survive cleaning with ordinary disinfectants, and it can grow at refrigerator temperatures.

Because the recall was announced on April 23, 2015, we are still within the window where people can become ill from the bacteria in this ice cream. Listeria symptoms can be delayed as long as 70 days after exposure. If you ate any of the recalled ice cream, watch yourself for these symptoms: flu-like illness, muscle aches, neck stiffness, high fever, vomiting, confusion, weakness, and diarrhea. Pregnant women are at high risk for complications such as miscarriage and stillbirth if they develop listeriosis, so contact your doctor if you feel at all sick.



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