FDA WARNING_LETTER - Black Sheep Egg Company, LLC - September 12, 2025

The FDA issued a Warning Letter to Black Sheep Egg Company, LLC following an inspection from August 20 to September 12, 2025. The agency determined that the company's shell eggs were adulterated under federal law because they were processed and held under insanitary conditions, potentially rendering them injurious to health. Additionally, serious violations of the Shell Egg regulation (21 CFR Part 118) were observed.

Key issues included the detection of multiple Salmonella serovars, with some strains matching clinical isolates, indicating a public health risk. Environmental samples showed widespread Salmonella contamination, including near food-contact surfaces. Insanitary conditions involved significant pest activity, such as numerous flies, open doors during processing, and moldy eggs. Sanitation deficiencies were noted, including persistent egg residues on equipment after cleaning, insufficient use of detergents/sanitizers, and power washing practices that risked spreading pathogens.

Furthermore, the company failed to comply with refrigeration requirements, holding nest run eggs at elevated ambient temperatures for extended periods prior to processing. It also lacked proper records demonstrating compliance with refrigeration standards during egg transportation. The FDA requires Black Sheep Egg Company, LLC to provide a written response within 15 working days, detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure to adequately address these concerns could result in legal enforcement actions.