FDA 483 - Lewis Sausage Company, Inc. - August 29, 2025

Lewis Sausage Company, Inc. in Burgaw, NC, received a Form 483 with two observations related to its pet food manufacturing. The firm failed to adequately identify and implement preventive controls for biological hazards like Salmonella and Listeria, as evidenced by positive product samples and inadequate mixing during production. Additionally, the company did not validate its identified process preventive controls to ensure they effectively control these hazards across all animal-based proteins used.