USA – Market of Choice, LLC – Warning Letter – Salmonella – Listeria – Allergens

FDA

You did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella, as a hazard requiring a preventive control in your ready-to-eat (RTE) salads, in accordance with 21 CFR 117.135(a)(1). Specifically, your document entitled “Food Safety Hazard Analysis Worksheet and HACCP Plan (b)(4) for Fresh Salads,” dated July 20, 2020, indicated that biological pathogens are not significant at the peel/trim/cut and packaging steps. However, your RTE fresh salads are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize environmental pathogens. Listeria monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE salads, exposed to the environment. Thus, your hazard analysis should have concluded that environmental pathogens such as Listeria monocytogenes are a hazard requiring preventive controls (i.e., sanitation controls, as required by 21 CFR 117.135(c)(3)) and that the controls need to be verified by environmental monitoring, e.g., for Listeria monocytogenes or an appropriate indicator organism as required by 21 CFR 117.165(a)(3)). Note that these controls and the environmental monitoring procedures must be written (21 CFR 117.135(b) and 165(b)(3)).