sks enterprises, inc., – FDA Warning Letter, Aug 14, 2012

The FDA issued a Warning Letter to SKS Enterprises, Inc., dba Honen Ranch, following inspections of five shell egg production facilities between May and August 2012. The inspections revealed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118), rendering their shell eggs adulterated under the FD&C Act.

Key violations include: 1. Failure to conduct environmental testing for SE in pullet environments at 14-16 weeks of age (D&C Ranch). 2. Failure to fully implement the SE prevention plan, specifically regarding vehicle washing/disinfection for visitors (Castle Ranch). 3. Failure to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, with observations of wild birds and structural gaps at multiple ranches (Fosberg & Griffin, Castle, Palm View). Additionally, SE prevention plans at all five ranches were deficient in addressing all required animal types. 4. Failure to perform environmental testing for SE at 4-6 weeks after the end of the molting process (Castle Ranch, Palm View Ranch). 5. Failure to maintain consistent rodent and fly monitoring records (Honen Ranch, Fosberg & Griffin, Castle, Palm View, D&C Ranch). 6. Environmental sampling plan not appropriate to poultry house layout, sampling only half of the cage rows in