FDA 483 - Raw Farm LLC - September 29, 2016

Organic Pastures Dairy Company, LLC, a dairy products manufacturer in Fresno, CA, was inspected by the FDA from September 27 to September 29, 2016. The inspection revealed several critical observations indicating non-compliance with regulatory standards and a previously issued permanent injunction.

The primary issue noted was the company's failure to adhere to a 2010 permanent injunction (Case 1:08-CV-01786-OWW-CSA). Specifically, Organic Pastures ceased displaying the mandated statement regarding not introducing unpasteurized raw milk or products into interstate commerce on their retail invoices and website, a requirement that had been in place for approximately 12 months after the injunction.

Additional observations focused on manufacturing conditions and sanitation. Inspectors identified condensate on the ceiling near uncovered cream tubs, signifying a failure to prevent contamination during food processing. Equipment maintenance was also deficient, with chipping paint and apparent rust on mixing equipment positioned directly over a kefir vat. Furthermore, raw materials and packaging in the dry storage area were inadequately protected, showing accumulated dust, cobwebs, and apparent rodent excreta. These findings necessitate prompt and comprehensive corrective actions by the company to ensure compliance and uphold product safety.