New Warning Letter Highlights FDA’s Expectations for Ready-to-Eat Food Manufacturers

By Ryan Maus
A recent FDA warning letter sent to an ice cream manufacturer highlights FDA’s expectations for the production of ready-to-eat (RTE) products. The ice cream manufacturer had initiated a recall on May 14, 2020 for mint chocolate chip ice cream made with spinach due to the presence of Listeria monocytogenes in the product. A subsequent FDA investigation found several critical food safety violations of the Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practice regulation. The following discussion summarizes FDA’s findings. Hazard Analysis and Risk-Based Preventive Controls Violations A hazard analysis of the entire production process is essential to determining whether pathogens may be present and require a risk-based preventive control. FDA determined the ice cream producer’s hazard analysis was insuffiecient because it did not identify environmental pathogens as a hazard for the inclusion mixing and blending process steps.
Because ice cream is a RTE product that is exposed to the environment before packaging, a preventive control to mitgate the risk of contamination from the environment should have been incorporated in the manufacturer’s food safe plan. Typically, Sanitation Preventive Controls are used for this purpose. However, since the manufactuere didn’t identify the risk of contamination from the environment, they did not provide an adequate control. The following observations led to a FDA “swabathon” that found L. monocytogenes in the producer’s environment. FDA noticed employees moving through a door between a freezer and the RTE production room. FDA swabbed and found L. monocytogenes on the bottom of this door. FDA also swabbed a broom used on the wet pathway coming out of the freezer door and found L. monocytogenes. L. monocytogenes was also found in an exterior ground drain.
Whole genome sequencing matched all isolates and confirmed the presence of a single strain of L. monocytogenes in the facility. Sanitation Preventive controls were apparently not in place or were ineffective. It is important to note that properly placed hygiene junctures allowing for hygiene segregation can prevent or control the spread of pathogens. The company’s own records indicated that L. monocytogenes was detected in several locations throughout the facility on multiple occasions. Although corrective actions were implemented after each incident, they were deemed inadequate by the FDA because of the repeated finding of L. monocytogenes. Corrective actions taken as a result of a root cause investigation of the contamination by the manufacturer were also deemed inadequate by the FDA. The manufacturer identified transportation of chocolate chip ingredients by dolly that allowed contact with the floor as the root cause of the product contamination. They corrected this by requiring the use of a cart. However, the cart was used between the inside RTE production room and outside areas without written procedures for cleaning and sanitizing the cart between the areas. Once again, a lack of sanitation controls and hygiene segregation created a potential for pathogen spread.