FDA WARNING_LETTER - Trillium Farms LLC - July 12, 2012

On November 29, 2012, the FDA issued a Warning Letter to Trillium Farms LLC following an inspection from June 27-July 12, 2012, of their shell egg production facilities in Croton, Mt. Victory, Harpster, Ohio, and their Johnstown headquarters. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118), rendering their shell eggs adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act and in violation of Section 361(a) of the Public Health Service Act.

Key violations include: 1. **Failure to perform environmental SE testing after induced molting:** Testing occurred outside the required 4-6 week timeframe at multiple layer sites (e.g., Layer site 1 house 12 tested at 9 weeks 4 days). The firm's response regarding new internal notification procedures was deemed insufficient as it did not address sample collection initiation. 2. **Failure to monitor for rodents by appropriate methods:** The firm's Biosecurity Plan lacked clear definitions for rodent index classifications and did not account for varying numbers of traps, potentially failing to indicate unacceptable rodent activity. While the firm stated they would adopt FDA guidance for rodent indexing, they did not specify the threshold for corrective