FDA 483 - Trillium Farm Holdings LLC - October 20, 2010

During a series of inspections conducted by the U.S. Food and Drug Administration (FDA) at Ohio Fresh Eggs, LLC, an egg producer, between September 22-28 and October 4, 6, and 20, 2010, a significant observation was documented on Form FDA 483. The inspection revealed that the company failed to comply with established regulatory requirements concerning the testing of its pullet environment for Salmonella Enteritidis (SE). Specifically, pullets at their Goshen facility were not tested for SE when they were 14 to 16 weeks of age, as required. Instead, these pullets were tested at approximately seven weeks old, indicating a substantial deviation from the mandated testing schedule. This observation points to a deficiency in following the regulatory framework designed to prevent SE contamination within the egg production process, likely falling under regulations such as 21 CFR Part 118 concerning SE prevention in poultry. While the FDA 483 serves as an advisory document and does not explicitly list required actions, Ohio Fresh Eggs, LLC is expected to promptly implement corrective measures to ensure their SE testing protocols align with regulatory mandates, thereby safeguarding public health by preventing the introduction of contaminated eggs into the food supply.