FDA WARNING_LETTER - Cooperstown Cheese Company, LLC - July 28, 2023

The FDA conducted an inspection of a ready-to-eat (RTE) raw milk cheese manufacturing facility from June 21 to July 28, 2023, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. mono) in multiple locations, including a food-contact surface (cutting board). This, coupled with a history of L. mono positive finished product samples dating back to 2017, led the FDA to determine that the RTE cheese products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include inadequate cleaning of food-contact surfaces (e.g., cheese/wax/salt residues on tables, old cheese residue on wooden aging boards stored on the floor), insufficient cleaning of non-food-contact surfaces (e.g., mold/rust on underside of stainless-steel table), and failure to maintain facilities in a clean and sanitary condition (e.g., mold on walls/baseboards, pitted floors, flaking door material, water buildup, dusty fan, exposed insulation). Several of these are repeat observations from previous FDA inspections. Equipment and utensils were also found not to be adequately cleanable or maintained, such as a heavily rusted curd press stand