FDA EIR - Caseificio Agricolo del Milanello - April 05, 2018

An FDA inspection of Caseificio Agricolo del Milanello, a Parmigiano-Reggiano cheese manufacturer located in Campegine, Italy, was conducted from April 3-5, 2018. This initial, full-scope preventive control inspection evaluated the firm's compliance with FDA's 21 CFR Part 117 Preventive Controls regulations for human food, as well as the compliance program for cheese products. The inspection identified two main observations documented on Form FDA 483. First, the company lacked evidence of a Preventive Controls Qualified Individual (PCQI), meaning no employee had received the required PCQI training or was supervised by such a person. This is critical for overseeing the food safety plan and validating preventive controls. Second, the facility's construction did not adequately support sanitary operations, specifically noting water hose stations in the brine and cheese-making areas that lacked proper backflow prevention. These open-ended hoses posed a potential backflow hazard by possibly submerging into process water. Company management acknowledged the deficiencies, committed to making necessary corrective changes, and pledged to submit a detailed written response to the FDA within 15 days, outlining their planned actions to address both the PCQI training gap and the sanitation concerns related to backflow prevention. No samples were collected, and no refusals were encountered during the inspection.