Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer – Drug Information Update

A federal court ordered a Tennessee-based company to stop selling over-the-counter (OTC) drug products until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in a consent decree. U.S. District Judge John T. Fowlkes, Jr. for the Western District of Tennessee entered a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee, the company’s owner, Melinda Menke, and its president, Elizabeth Jumet. According to the complaint filed with the consent decree, Keystone manufactured and distributed OTC hair care and skin care products that violated federal law. Keystone’s drug products were not manufactured, processed, packed or held according to CGMP requirements. For example, Keystone failed to adequately investigate sources of contamination found in some of its products and failed to ensure its drug products met their specifications before releasing them to consumers. Some of Keystone’s drugs were also misbranded because the product labels did not include adequate directions for use or other label requirements for OTC drug products. The consent decree requires Keystone to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company complies with the FD&C Act and its implementing regulations. Under the consent decree, Keystone may not resume operations until it establishes and implements a comprehensive quality control system and receives authorization from the FDA, among other requirements. For more information, please visit: Keystone Laboratories, Inc. Consent Decree.