OTC Drugmaker in Tennessee Hit With Consent Decree

October 31, 2018

Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements.

According to the complaint filed with the consent decree, Keystone manufactured and distributed OTC hair care and skin care products that violated federal law. U.S. District Judge John T. Fowlkes, Jr. for the Western District of Tennessee entered the consent decree against Keystone, the company’s owner, Melinda Menke, and its president, Elizabeth Jumet.

The facility drew a warning letter from the FDA in March 2013, but agency officials found repeat violations during inspections in February 2016 and November 2017.

The facility failed to adequately investigate sources of contamination found in some of its products and failed to ensure the drug products met specifications. Some of drugs were also misbranded because the labels lacked adequate directions for use or other label requirements for OTC drug products, the agency said.

Under the consent decree, the facility may not resume operations until it implements a comprehensive quality control system and the FDA deems it to be in compliance with CGMP requirements.

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