Tennessee Over-The-Counter Drug Manufacturer Ordered to Cease Operations
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Tennessee Over-The-Counter Drug Manufacturer Ordered to Cease Operations

company repeatedly failed to monitor product specifications and had misbranded products

October 24, 2018

A federal court ordered Tennessee-based company Keystone Laboratories to stop selling over-the-counter (OTC) drug products until the company complies with the Federal Food, Drug, and Cosmetic Act (FFDCA) and other requirements listed in a consent decree. Keystone Laboratories manufactured and distributed OTC hair care and skin care products that violated federal law.

Failed to ensure specifications; misbranded products

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's drug products were not manufactured, processed, packed or held according to current good manufacturing practice 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.

Must Cease Operations

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 FFDCA 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 U.S. Food and Drug Administration (FDA), among other requirements.

Previously, the FDA issued a warning letter to 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.