Tennessee OTC Company Receives Consent Decree

Pharmaceutical Technology Editors

A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.

FDA announced on Oct. 23, 2018 that a federal court judge had ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter (OTC) drug products. The US District Judge for the Western District of Tennessee entered into a consent decree of permanent injunction against the company and the company’s owner and president for manufacturing and distributing OTC haircare and skincare products not manufactured under current good manufacturing practices.

According to FDA, the company did not investigate sources of contamination of some products nor did it ensure that its products met specifications before release to the public. “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,” FDA stated in a press release. An FDA warning letter issued in March 2013 cited the company for similar violations. Repeat observations were found in later FDA inspections as well.

Keystone must cease operations until it completes corrective actions and has an independent expert inspect its facility. Under the consent decree, the company must wait for FDA to authorize the company to resume operations.

Source: FDA