FDA WARNING_LETTER - Lewis Sausage Company, Inc. - August 29, 2025

Lewis Sausage Company Inc., located in Burgaw, North Carolina, was issued a formal warning letter by the FDA following a joint inspection conducted from August 25 through August 29, 2025. This inspection, carried out alongside state agriculture officials, revealed significant safety violations in the production of the firm"s pet food products. Laboratory testing confirmed that multiple batches of chicken and turkey pet foods were contaminated with Salmonella and Listeria monocytogenes, rendering the products adulterated and potentially harmful to animal and human health.

The main issues identified involve failures to comply with the Federal Food, Drug, and Cosmetic Act regarding preventive controls. Specifically, the company failed to implement and validate effective measures to eliminate biological hazards. While the company attempted to use probiotics and high-pressure processing as safety steps, they provided insufficient scientific evidence to prove these methods reduced pathogens to safe levels. Furthermore, investigators observed that staff did not follow established procedures for mixing times, which are critical for ensuring product safety.

Lewis Sausage Company is required to investigate the root causes of these failures and implement corrective actions to ensure future compliance with federal safety standards. The firm must provide a written response to the FDA within 15 working days detailing the specific steps taken to address these violations and prevent their recurrence. Failure to rectify these issues may lead to further legal or regulatory action, such as product seizures or injunctions.