FDA WARNING_LETTER - Warren Farms Llp - August 09, 2012

On August 7-9, 2012, an FDA inspection of Warren Farms, LLP's shell egg production facility in Union Grove, AL, revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These violations render the 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: - Failure to maintain records documenting environmental sampling procedures, specifically the sampling plan (21 CFR 118.10(a)(3)(v)). The firm's August 29, 2012, response stated adjustments were being made but provided no revised plan or records. - Failure to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses (21 CFR 118.4(b)(4)), evidenced by a dog entering a house and observed gaps in barriers. - Failure to maintain records documenting compliance with biosecurity measures (21 CFR 118.10(a)(3)(i)), specifically employee agreements regarding bird ownership and general biosecurity records from July 2010 to January 2012. - Failure to have and implement a written SE Prevention Plan with an appropriate fly