FDA EIR - Raw Farm LLC - February 12, 2021

An FDA inspection of Organic Pastures Dairy Company LLC in Fresno, CA, was conducted from February 2 to February 12, 2021. This inspection was directed by Compliance Program Guidance Manuals for Preventive Controls and Nutritional Labeling, and was a follow-up to a 2010 consent decree (case 1:08-CV-01786-OWW-GSA).

Investigators issued a Form FDA 483 citing significant observations. Primary issues included the company's hazard analysis failing to identify known environmental pathogen recontamination risks during raw cheddar cheese processing, specifically concerning employee handling and equipment contact. The inspection also found that process control procedures for cheese aging lacked specific parameters and continuous temperature monitoring, and there was no comprehensive written preventive control plan for this critical step. Furthermore, operations were not conducted under conditions to minimize contamination, evidenced by unsmooth, cracked welds on a whey cheese strainer and frayed plastic tools in direct contact with food.

Additional deficiencies, though not on the Form FDA 483, were discussed, such as improper dry ingredient storage conditions, an unidentified chemical in the production area, inadequate monitoring procedures for process and sanitation controls, and the absence of a written supply-chain program.

Management, represented by President Mr. Aaron L. McAfee, acknowledged the observations and committed to submitting a written response within 15 business days, addressing all identified issues. The FDA emphasized the potential for legal sanctions, including seizure, injunction, or prosecution, if serious conditions are not voluntarily corrected.