FDA WARNING_LETTER - Quality Egg LLC - August 30, 2010

This FDA Warning Letter (Ref. KAN 2011-01) was issued to Quality Egg LLC following an inspection from August 12-30, 2010, at their Galt, Clarion, and Dows, Iowa facilities. The inspection was prompted by a nationwide increase in Salmonella Enteritidis (SE) cases, with the firm implicated as a source of contaminated shell eggs.

FDA laboratory analyses confirmed SE presence in egg laying barns (Layer #2 and #4, Clarion, IA) and in feed ingredients and finished feed at the Galt, IA feed mill. The firm was found to have serious deviations from 21 CFR Part 118, the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation. These failures render shell eggs in violation of the Public Health Service Act (42 U.S.C. 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.

Violations include: * **Failure to implement the SE Prevention Plan (21 CFR 118.4):** * Failure to eliminate rodent hiding/nesting sites (e.g., wood boards, unused structures, high grass). * Failure