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.
“Americans expect and deserve OTC drug products that are safe and effective and meet appropriate standards for quality. To ensure safe use by consumers, OTC drug products must also include specific information on product labels,” said the Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, Donald D. Ashley, J.D. “Despite previous warnings, Keystone placed consumers at risk by manufacturing OTC drug products in violation of current good manufacturing practice (CGMP) requirements and failed to include adequate directions for use on its product labels. The FDA remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk.”
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.
Previously, the FDA issued awarning letterto Keystone in March 2013 for similar violations as cited in the complaint. Following the warning letter, the FDA inspected the facility in February 2016 and November 2017 and observed repeat violations.
The U.S. Department of Justice filed the complaint on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.