Federal judge enters consent decree against Delta Pharma

A U.S. district court judge has entered a consent decree of permanent injunction between the United States and Delta Pharma, of Ripley, MS, and two of the company's top officials. The complaint holds that despite Delta Pharma's promises to resolve deficiencies, the company continued to violate the law.

A U.S. district court judge has entered a consent decree of permanent injunction between the United States and Delta Pharma, of Ripley, MS, and two of the company's top officials. The complaint holds that despite Delta Pharma's promises to resolve deficiencies, the company continued to violate the law. Under the consent decree, Delta Pharma, company president Tommy T. Simpson, and Charles Michael Harrison, vice president and pharmacist-in-charge, are prohibited from manufacturing, processing, packing, holding, or distributing Delta Pharma's drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA's regulations. According to the complaint, Delta Pharma manufactured and distributed purportedly sterile drug products that were adulterated under the FD&C Act because they were made in insanitary conditions and in violation of current good manufacturing practice requirements. Additionally, the complaint claims that Delta Pharma manufactured and distributed unapproved new drugs and products that were misbranded because their labels did not include adequate directions for use.