FDA 483 - Best Buy Bones Inc. - May 03, 2024

Best Buy Bones Inc., a pet treat manufacturer located in Mount Morris, MI, underwent an FDA inspection from March 18 to May 3, 2024. This inspection resulted in several significant observations, many of which were repeat issues from a prior inspection in February 2023. The deficiencies primarily relate to the company's food safety system and its adherence to regulations concerning preventive controls for animal food.

Key issues included the firm's failure to implement a comprehensive written supply-chain program, specifically lacking essential documentation such as certificates of analysis or letters of guarantee for incoming ingredients and packaging materials. Best Buy Bones Inc. also failed to adequately identify and evaluate all foreseeable hazards for its animal food products, notably by not applying metal detection to antlers during processing despite the use of cutting equipment.

Additional observations noted the absence of written procedures for critical preventive controls, such as visual inspection of blades used in trimming. Monitoring records for existing preventive controls were found to be incomplete, particularly for sanitation activities in production areas. Furthermore, the firm did not appropriately identify and implement preventive controls to minimize or prevent hazards, as evidenced by its failure to recognize the cooking process for pork hearts as a vital control for biological pathogens.

These observations indicate that Best Buy Bones Inc. must promptly review and enhance its food safety management practices and documentation to ensure compliance with FDA regulations and the continued safety of its pet treat products. The company is expected to provide a response outlining its corrective actions.