Consent Decree Entered Against Tennessee-based OTC Drug Manufacturer

OCTOBER 23, 2018
US District Judge John T. Fowlkes, Jr. for the Western District of Tennessee, has ordered officials with Keystone Laboratories, of Memphis, 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.

According to the complaint filed with the consent decree, Keystone's products were not manufactured, processed, packed or held according to CGMP requirements. For example, Keystone officials 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 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 US Department of Justice filed the complaint on behalf of the FDA.