FDA WARNING_LETTER - Fremont Farms L.C. - June 29, 2011

The FDA inspected Fremont Farms L.C.'s shell egg production facility in Fremont, Iowa, from June 23-29, 2011, and found serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These violations render the shell eggs adulterated under the Federal Food, Drug, and Cosmetic Act and in violation of the Public Health Service Act.

Key violations include: 1. **Inadequate Cleaning and Disinfection:** Failure to remove all visible manure from House 1 after an SE positive environmental test before repopulation, as required by 21 CFR 118.4(d). 2. **Inappropriate Environmental Sampling Plan:** The sampling plan did not include provisions for sampling egg belts or manure pits (21 CFR 118.7(a)). Additionally, the firm's chosen environmental testing methods were not recognized by FDA as equivalent to the specified method (21 CFR 118.8(a)). 3. **Deficient SE Prevention Plan:** The written plan lacked measures for preventing cross-contamination when equipment or persons move between poultry houses, preventing entry of stray animals, and removing debris/vegetation outside houses (21 CFR 118.4(b)(2), (b)(3), (b)(4), (c)(3)). It also failed to require