FDA 483_RESPONSE - Organic Pastures - October 09, 2019

Organic Pastures Dairy Company, LLC underwent an FDA inspection from September 23 to October 9, 2019, led by investigators Ismael Garibay and Joseph Willems. The inspection revealed several compliance issues, prompting the issuance of an FDA Form 483 on October 9, 2019. Key violations included the continued manufacture of pet food despite a court order, improper labeling on invoices and packaging slips, and unauthorized sharing of health claims on social media.

In response, Organic Pastures ceased all pet food production and sales, retaining unsold inventory pending FDA approval. The company has complied with labeling requirements by updating invoices and packaging slips and has trained staff accordingly. They have also removed shared social media posts that implied health benefits of raw milk, ensuring future compliance by instructing their marketing team to avoid sharing such content.

To address broader compliance issues, Organic Pastures has enhanced its Food Safety Plan, aligning with Good Manufacturing Practices (GMP) audit findings. Improvements include staff training documentation, sanitizer concentration checks, pest control reports, and updated safety protocols such as pH calibration and temperature logs. The company has also improved its recall plan, supply chain management, and facility maintenance, including replacing corroded doors and removing condensation and peeling paint.

Organic Pastures seeks FDA approval to resume pet food production, contingent on the satisfactory implementation of these corrective actions and compliance with regulatory standards under Subpart 507. They have invited a follow-up inspection to validate these improvements.