FDA 483 - Quanto Alimentos Industry and Commerce, LTDA - November 12, 2019

An FDA inspection of Quanto Alimentos Industria e Comercio, LTDA, a manufacturer of pig ear and dog treats located in Sao Leopoldo, Brazil, was conducted from November 11-12, 2019. The inspection resulted in an FDA Form 483, detailing a significant observation regarding the company's food safety practices. The main issue identified was the firm's failure to adequately verify the consistent implementation and effectiveness of its preventive controls through environmental monitoring.

Specifically, the environmental monitoring program designed to verify sanitation controls for Salmonella in the pig ear/strip production areas was deemed insufficient. Salmonella was recognized as an environmental pathogen requiring a preventive control. The observed practice involved collecting only one environmental swab for Salmonella from a product-contact surface on one of several product-sorting tables after sanitization and before production, alternating between tables. This limited sampling was considered inadequate to ensure the effectiveness of their sanitation controls.

Issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, the FDA 483 represents inspectional observations and is not a final determination of compliance. Quanto Alimentos is expected to take prompt and appropriate corrective actions to address these deficiencies, particularly by strengthening its environmental monitoring program to ensure the consistent effectiveness of its sanitation preventive controls for identified hazards.