Federal judge enters consent decree against Medistat

A U.S. District Judge entered a consent decree of permanent injunction on behalf of the U.S. Food and Drug Administration (FDA) between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, quality manager, and pharmacist-in-charge. The consent decree prohibits those named from manufacturing, holding or distributing drugs until they comply with the Federal Food, Drug and Cosmetic Act and its regulations, in addition to other requirements. Medistat manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements. Read the FDA news release.