K-Brand Farms – FDA Warning Letter, Dec 2, 2011

On April 3, 2012, the FDA issued a Warning Letter to K-Brand Farms following an inspection from November 30 to December 2, 2011. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR 118), rendering their shell eggs adulterated under the FFD&C Act.

Key violations included: * **Failure to maintain records for biosecurity measures** (21 CFR 118.10(a)(3)(i)), such as tool disinfection, stray animal trap monitoring, employee bird ownership policy, employee biosecurity training, and visitor guidelines. * **Failure to maintain records for refrigeration requirements** (21 CFR 118.10(a)(3)(iv)), specifically for delivery trailers, and lacking a corrective action procedure for temperature excursions. * **Failure to prevent stray animals from entering poultry houses** (21 CFR 118.4(b)(4)), with observations of live cats, missing bird wire, and rodent remains. * **Failure to remove debris inside and outside poultry houses** (21 CFR 118.4(c)(3)) that could harbor pests. * **Failure to include time of activity, farm name, and location on required records** (21 CFR 118.10(