FDA 483 - Lewis Sausage Company, Inc. - May 17, 2024

Lewis Sausage Company, Inc., a raw pet food manufacturer in Burgaw, NC, was cited for significant deficiencies in its preventive controls and hazard analysis. The inspection revealed inadequate measures to control microbial hazards like Salmonella, Listeria, and E.coli, including issues with validation studies, monitoring, and sampling programs, with one observation being a repeat. Additionally, the firm failed to identify and evaluate nutrient deficiency and toxicity hazards for its "Complete and Balanced" pet food products.