FDA 483 - Bosco and Roxy's, Inc - April 12, 2026

An unnamed firm underwent an inspection by the U.S. Food and Drug Administration (FDA) from August 8 to August 12, 2022. This inspection led to the issuance of an FDA Form 483, which documents observations of conditions or practices that may indicate potential non-compliance with regulatory standards.

The main issue identified was the firm's failure to adequately evaluate known or reasonably foreseeable hazards for the animal food it manufactures, processes, packs, or holds. Specifically, the FDA observed that the firm did not identify and assess the hazard of patulin in an ingredient used in its baked and decorated dog treats. Patulin is a recognized hazard commonly associated with apple products, implying a potential contamination risk in the firm's pet food products.

These findings were reported in accordance with Section 704(b) of the Federal Food, Drug, and Cosmetic Act. This provision requires FDA officers to report any conditions or practices that suggest food may be adulterated or prepared under unsanitary conditions. While the FDA Form 483 is not a final determination of regulatory compliance, it serves to inform the firm of the inspectional findings. The firm is expected to respond to these observations by either discussing objections or submitting details of corrective actions already implemented or planned to address the identified issues and ensure compliance with applicable laws and regulations.