Regulatory Focus™ > News Articles > 10 > District Court Issues Injunction Against Tennessee OTC Drugmaker

District Court Issues Injunction Against Tennessee OTC Drugmaker

Posted 23 October 2018 | By Michael Mezher 

District Court Issues Injunction Against Tennessee OTC Drugmaker

A US district court judge on Tuesday issued a consent decree of permanent injunction against Tennessee over-the-counter (OTC) drugmaker Keystone Laboratories barring the company from manufacturing or distributing drugs until it complies with the requirements in the decree.
The injunction comes after the Department of Justice, on behalf of the US Food and Drug Administration (FDA), filed a complaint against the company and its owner and operator in September.
According to the complaint, Keystone violated the Food, Drug and Cosmetic Act (FDCA) by distributing OTC drug products that were not manufactured in accordance with current good manufacturing practices (cGMP) and in some cases did not have adequate labeling. The company has agreed to be bound by the consent decree.
“Despite previous warnings, Keystone placed consumers at risk by manufacturing OTC drug product in violation of current good manufacturing practice requirements and failed to include adequate directions for use on its product labels,” said Donald Ashley, director of the Center for Drug Evaluation and Research’s Office of Compliance.
In 2013, FDA sent a warning letter to Keystone citing similar violations to those laid out in the complaint and identified repeat violations in two subsequent inspections in February 2016 and November 2017.
In one case, FDA said the company released a batch of a hair product “despite test results that suggested contamination by the potentially harmful bacteria Staphylococcus aureus” and failed to adequately investigate sources of contamination.
Under the consent decree, Keystone must halt its operations until it completes the corrective actions laid out in the consent decree, which include hiring an independent GMP consultant to inspect its facility, implementing a comprehensive quality control system.
The company will also be required to receive authorization from FDA before resuming operations.
FDA, Department of Justice


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.