FDA 483 - GOLD STAR DISTRIBUTION INC - December 18, 2025

Between November 17 and December 18, 2025, the FDA inspected Gold Star Distribution Inc., a multi-commodity warehouse located in Minneapolis, Minnesota. The inspection revealed critical systemic failures in maintaining a safe and sanitary environment for the storage of human and animal food, over-the-counter drugs, medical devices, and cosmetics. The primary violation involved a severe and widespread pest infestation. Investigators documented numerous live and dead rodents, birds, and insects throughout the facility. Significant quantities of rodent droppings, urine stains, and nesting materials were found directly on or inside product packaging. Additionally, the facility failed to maintain basic sanitary standards, reporting issues such as leaking ceilings, structural gaps that allowed pest entry, and overflowing refuse areas. A major safety concern was also noted regarding the improper storage of toxic chemicals, including motor oil and diesel exhaust fluid, which were kept in immediate proximity to food products. Furthermore, the firm failed to monitor or control temperature and humidity for pharmaceutical products. These findings indicate that the company is operating in violation of the Federal Food, Drug, and Cosmetic Act by holding products under unsanitary conditions where they may have become contaminated with filth. Gold Star Distribution is required to conduct comprehensive internal self-audits to identify and correct these violations. The firm must provide the FDA with a formal response detailing their completed or planned corrective actions to ensure future regulatory compliance.