FDA 483 - Raw Farm LLC - February 12, 2021

During an FDA inspection conducted from February 2-12, 2021, Organic Pastures Dairy Company LLC, a manufacturer of raw milk, butter, kefir, and pet food in Fresno, CA, received a Form FDA 483. This document, issued under the Federal Food, Drug, and Cosmetic Act, outlined several significant observations regarding the firm's food safety practices. The main violations centered on critical deficiencies in their hazard analysis and preventive controls, particularly for raw cheddar cheese production.

The company failed to identify and control various known hazards, including the potential for recontamination by environmental pathogens during processing due to inadequate employee hygiene and unsanitized equipment, and the absence of a written plan for environmental *Salmonella* and *Listeria monocytogenes* monitoring. Other concerns included the lack of controls for undeclared allergens from incorrect labeling, insufficient time/temperature controls to prevent bacterial growth (specifically *Listeria monocytogenes*) during storage and distribution, and the absence of metal inclusion as a hazard in their cutting and shredding processes without corresponding detection methods.

Furthermore, process control procedures were found lacking, with no written protocols for the 60-day cheese aging process, including continuous temperature monitoring. The inspection also identified conditions that could lead to food contamination, such as a whey cheese strainer with cracked welds and frayed plastic on food-contact tools. Organic Pastures Dairy Company LLC is expected to promptly implement comprehensive corrective actions to address these observations and ensure compliance with food safety regulations.