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

During an inspection conducted from May 13-17, 2024, the FDA issued a Form 483 to Lewis Sausage Company, Inc., a raw pet food manufacturer in Burgaw, NC. The observations indicate significant deviations from regulatory requirements under the Federal Food, Drug, and Cosmetic Act, particularly concerning the prevention of hazards in animal food. The primary finding detailed the company's failure to establish and implement adequate preventive controls to minimize or prevent the growth of undesirable microorganisms such as Salmonella, E. coli, and Listeria. A key issue was the insufficient validation of a spray application process intended to mitigate these pathogens, alongside inconsistent monitoring of the spray nozzles. Furthermore, the firm's environmental monitoring program was found to be inadequate in frequency and scope, notably omitting E. coli testing despite it being an identified hazard. The finished product sampling program for these pathogens was also deemed insufficient, a concern that was identified as a repeat observation from a prior inspection. A second critical observation noted that the company's hazard analysis did not account for potential nutrient deficiency or toxicity hazards. This oversight is particularly relevant given that the firm produces pet foods labeled "Complete and Balanced" for both cats and dogs. Lewis Sausage Company, Inc. is expected to address these serious deficiencies and implement comprehensive corrective actions to ensure compliance with food safety standards and the safety of its animal food products.