FDA 483 - DO & CO Detroit, Inc. - August 18, 2025

An FDA inspection conducted at DO & CO Detroit, Inc. between July 17, 2025, and August 18, 2025, identified significant operational deficiencies. The primary observation, issued under the Federal Food, Drug and Cosmetic Act, highlighted the company's failure to maintain conditions and controls adequate to minimize microbial growth. Specifically, the firm did not implement effective corrective actions to address persistent Listeria monocytogenes contamination in its dish room, which repeatedly yielded positive environmental samples from May 7, 2025, through the inspection's conclusion. The FDA noted that the company’s responses did not sufficiently reduce the likelihood of recurrence, thoroughly evaluate the safety of all potentially affected food, or prevent adulterated products from entering commerce. The dish room is critical for sanitizing equipment used for Ready-To-Eat (RTE) foods at the Trade Center facility, on aircraft, and sometimes at the Grace Lake facility. Furthermore, uncontrolled movement of equipment and personnel between the company's three facilities through areas where RTE foods are exposed created a significant contamination risk. DO & CO Detroit, Inc. is required to promptly address these insanitary conditions by implementing comprehensive and effective corrective and preventive actions. These actions must ensure robust microbial control, particularly for Listeria, assess the safety of all food products, and establish strict controls over traffic flow and sanitation to safeguard public health and comply with regulatory standards.