FDA 483 - Krispy Kreme Doughnut Corporation - July 15, 2022

From July 14 to July 15, 2022, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Krispy Kreme Doughnut Corporation manufacturing facility in Columbus, Ohio. This assessment, conducted under the regulatory authority of the Federal Food, Drug, and Cosmetic (FD&C) Act, identified several significant operational and sanitary deficiencies. Primary violations included the failure to maintain the plant in a clean and repaired state, evidenced by food debris on machinery and cracked walls in production areas. Investigators also observed substantial contamination risks, such as dust accumulation on ceiling vents located directly above ready-to-eat donuts and the improper storage of ingredients on the floor or near cleaning chemicals. Furthermore, the facility lacked adequate sanitary facilities, with hand-washing stations missing soap and paper towels or being used for cleaning equipment. Finally, food-contact equipment was poorly maintained, featuring chipped bowls and mixing tools stored on rusted surfaces. While this report does not constitute a final legal determination of non-compliance, the company is required to address these observations. Krispy Kreme should provide a written response to the FDA detailing its planned or completed corrective actions to resolve these sanitary issues.