In its inspection of a raw milk cheese manufacturer, FDA inspectors detected repeated incidence of Listeria monocytogenes (Lm) and other Listeria species in the environment and Lm on food contact surfaces, demonstrating that the facility’s sanitation efforts were inadequate to effectively control pathogens to prevent contamination of food. Specific sanitation observations noted by FDA were: residues on food-contact surfaces, including steel and plastic tables and wooden boards that were recently cleaned and sanitized, and non-food contact surfaces, including the undersides of stainless steel tables.
Sanitary design was also noted as a concern, which was evidenced by rust, chipping paint-like material, and wooden boards used for aging cheese with rough, uneven surfaces, preventing effective cleaning. And maintenance concerns included pitted floors that had rough surfaces allowing for standing water and mold-like substances on the ceiling.
Effective sanitation and maintenance, along with sanitary design allowing for thorough cleaning are essential to food safety. And the repeat history of positive Listeria findings in this facility’s processing environment, along with CGMP issues, cause FDA to have continued concern about its ability to maintain a sanitary environment. With recommendations for the facility to continue to identify potential harborage sites and source(s) of the organism in the processing environment and implement the necessary methods and controls to ensure Lm does not contaminate the environment or RTE food products, the FDA indicated its plan to verify the effectiveness of the corrective actions and the facility’s ability to maintain a sanitary environment during its next inspection.
