FDA EIR - Organic Pastures - October 09, 2019

An FDA inspection of Organic Pastures Dairy Company LLC, located in Fresno, CA, was conducted from September 23 to October 9, 2019. The inspection primarily focused on the company's adherence to a permanent injunction (Consent decree case 1:08-CV-01786-OWW-GSA, filed 04/20/2010), in addition to general food safety regulations under the Federal Food, Drug, and Cosmetic Act. Investigators issued a Form FDA 483 detailing multiple repeated violations of the court order.

Key issues included the unauthorized introduction of raw milk products (specifically raw kefir pet food) into interstate commerce, the failure to include a required statement on invoices and packaging slips regarding interstate commerce restrictions, and promoting raw milk's health benefits (e.g., "Less asthma") on social media. The company also failed to notify large commercial buyers that raw milk products could not be sold or distributed outside California.

Additional deficiencies discussed with management included inadequate employee training records (21 CFR Part 507.202), an improperly enclosed kefir manufacturing room, unmaintained food contact surfaces, undocumented pH meter calibrations, and non-compliance with Food Safety Plan requirements (21 CFR Part 117) for human food raw milk products.

Mr. Aaron L. McAfee, President, received the Form FDA 483 and committed to providing a written response within 15 business days. He was cautioned about potential legal sanctions, such as seizure, injunction, or civil penalties, if the serious conditions were not voluntarily corrected.