- On September 21, 2026, the U.S. District Court for the District of Minnesota ordered Minnesota-based Gold Star Distributions, Inc. and its owner to stop distributing FDA-regulated products until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal legal requirements. The consent decree follows a 2025 FDA investigation that found persistent insanitary conditions, including severe rodent and pest infestations that risked contaminating food, drugs, cosmetics, and medical devices.
- The complaint alleges that Gold Star stored FDA-regulated products in insanitary conditions that risked contamination. It further alleges that they failed to store drugs in accordance with current good manufacturing practice requirements.
- Federal and state inspections repeatedly identified rodent infestations and insanitary conditions at Gold Star’s facility from 2013 through 2025. During a follow-up inspection in 2025, FDA found extensive rodent and pest activity, contaminated product packaging, and improper waste accumulation that threatened the safety of the FDA-regulated products. The Minnesota Department of Agriculture also issued a notice of embargo and cease and desist order on all food products and operations in November 2025, and revoked Gold Star’s wholesale license.
- The consent decree requires that Gold Star correct sanitation, pest-control, storage, and structural deficiencies. Gold Star is also required to destroy all FDA-regulated products and pass inspections by independent experts and the FDA. Operations may resume only after receiving written FDA approval.
