FDA EIR - Raw Farm LLC - September 29, 2016

An FDA inspection of Organic Pastures Dairy Company, LLC. in Fresno, CA, was conducted from September 27-29, 2016. The inspection aimed to assess compliance with domestic food safety regulations, cheese and cheese product guidelines, food labeling requirements, and a standing consent decree (Case 1:08-CV-01786-OWW-GSA, filed 04/20/2010). During the inspection, the FDA issued a Form FDA 483, highlighting several significant observations. These included a deviation from the procedural requirements of the existing consent decree, specifically the failure to continuously display a required statement regarding the introduction of unpasteurized raw milk products into interstate commerce on invoices and the company website. Further issues involved deficiencies in manufacturing controls to minimize contamination, evidenced by chipping paint and apparent rust on mixing equipment directly over a kefir vat. The inspection also noted a failure to adequately protect raw materials from contamination, as observed with accumulated dust, cobwebs, and apparent rodent excreta in the dry storage area where packaging and raw materials were kept. Management acknowledged the observations and committed to making necessary corrections, including submitting a written response within 15 days. The firm was reminded of potential legal sanctions, such as seizure, injunction, civil money penalties, and prosecution, should the identified violations persist.