Ohio Fresh Eggs LLC – FDA Warning Letter, Dec 20, 2010

On December 20, 2010, the FDA issued a Warning Letter to Ohio Fresh Eggs, LLC, following a review of their shell egg production records from November 2 to November 29, 2010. This review was prompted by 13 FDA environmental samples from four egg layer sites testing positive for Salmonella Enteritidis (SE).

The FDA identified serious deviations from the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These deviations render the shell eggs in violation of the Public Health Service Act (42 U.S.C. Section 264(a)) and adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.A. 342(a)(4)) due to insanitary conditions.

Specific violations include: 1. **Failure to divert SE-positive eggs for treatment:** Ohio Fresh Eggs, LLC, failed to divert eggs to a treatment achieving a 5-log destruction of SE after two consecutive SE-positive egg tests from Site (b)(4), House (b)(4). On October 7, 2010, 798 cases of eggs were shipped to a table egg processor instead of a treatment facility, leading to a recall initiated on November 5, 2010,