FDA WARNING_LETTER - Sixdog Investments, LLC - May 29, 2014

On April 28-May 29, 2014, the FDA inspected Six Dog Investments, LLC (DBA Sixdog Farms) and found significant violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render shell eggs adulterated under Section 402(a)(4) of the FD&C Act and in violation of Section 361(a) of the PHS Act.

Key violations include: 1. Failure to implement the SE prevention plan and maintain records for SE-monitored pullets (21 CFR 118.4, 118.10(a)(2)). 2. Failure to raise pullets under SE-monitored conditions, including environmental testing at 14-16 weeks of age (21 CFR 118.4(a)). 3. Failure to conduct environmental testing in poultry houses for laying hens 40-45 weeks of age (21 CFR 118.5(a)). 4. Failure to implement the SE prevention plan, including proper cleaning and disinfection of poultry houses after positive SE tests and before new hens were added, and failure to maintain related records (21 CFR 118.4, 118.4(d), 118.10(a)(