FDA 483 - Anabe Protein Industry and Commerce Ltda. - November 08, 2019

During an FDA inspection conducted on November 7-8, 2019, Anabe Industria e Comercio de Proteinas Ltda., a Brazilian manufacturer of pig ear dog chews, received a Form FDA 483 outlining significant observations related to its food safety preventive controls. The inspection revealed four key issues. First, the company failed to perform environmental monitoring in areas where pig ears are handled and packaged, which is crucial for verifying the effectiveness of sanitation controls against Salmonella, a recognized hazard. Second, product testing for Salmonella was inadequate, being conducted only upon specific customer requests rather than at a frequency sufficient to verify preventive control effectiveness. Third, the firm lacked established and adequately frequent written procedures for monitoring its heat treatment process, a critical preventive control designed to eliminate Salmonella. Lastly, monitoring records for this process control were found to be inaccurate, often documenting the minimum required temperature instead of the actual observed temperature, compromising record integrity. These observations highlight a need for Anabe Industria e Comercio de Proteinas Ltda. to implement robust corrective actions to ensure compliance with food safety regulations and the Federal Food, Drug, and Cosmetic Act.