FDA 483 - Custom Pet SAS - November 19, 2019

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 18-19, 2019, Custom Pet SAS, a dog treat manufacturer based in Bogota, Colombia, was issued an FDA Form 483 detailing two significant observations. These observations highlight areas requiring attention to ensure compliance with animal food safety regulations under the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the company's oversight of its suppliers. Custom Pet SAS's onsite audit of a supplier, responsible for controlling Salmonella hazards through specific treatments, did not include verification of the supplier's process control records. This indicated a lack of documented evidence confirming the effective control of the Salmonella hazard by the supplier.

The second observation pointed to a critical gap in Custom Pet SAS's internal hazard analysis. The firm had not adequately identified Salmonella as a known or reasonably foreseeable environmental pathogen within its facility's hazard analysis for the animal food produced. This omission was noted despite the company's own environmental sampling program routinely testing for Salmonella.

Custom Pet SAS is required to address these inspectional observations by implementing robust corrective actions. These actions should focus on enhancing supplier management practices, particularly regarding hazard control verification, and strengthening the comprehensive evaluation of environmental pathogens in their hazard analysis to ensure the ongoing safety and quality of their dog treat products.