Tennessee Skin/Haircare Company Ordered To Halt Operations

A federal court ordered a Tennessee-based company 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 Laboratories, Memphis, TN, manufactured and distributed OTC hair care and skin care products that violated federal law.
 
“Americans expect and deserve OTC drug products that are safe and effective and meet appropriate standards for quality. To ensure safe use by consumers, OTC drug products must also include specific information on product labels,” said the Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, Donald D. Ashley, J.D. “Despite previous warnings, Keystone placed consumers at risk by manufacturing OTC drug products in violation of current good manufacturing practice (CGMP) requirements and failed to include adequate directions for use on its product labels. The FDA remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk.”

U.S. District Judge John T. Fowlkes, Jr. for the Western District of Tennessee entered a consent decree of permanent injunction against Keystone Laboratories, the company’s owner, Melinda Menke, and its president, Elizabeth Jumet. Keystone’s drug products were not manufactured, processed, packed or held according to CGMP 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.

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 U.S. Department of Justice filed the complaint on behalf of the FDA.

In the March 2013 warning letter, FDA noted that in inspections on August 15, 16, 20, 21, 23, and 29, 2012 of the pharmaceutical manufacturing facility. an investigator identified significant violations of CGMP regulations for finished pharmaceuticals.
 
In addition to the CGMP violations,  FDA stated that Keystone manufacturers numerous products that are presented as cosmetics. Based on the labeling, such products are drugs as defined by Section 201(g)(1) of the Act [21 USC 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. 
 
In 2012, the investigator observed specific vrepeat iolations including, but not limited to failure to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (condensate leaking into a bucket that was secured to the ceiling over the production area, peeling paint on the floors, walls and support beams in the production area); failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (deep scratches and rust like stains in vessels used to measure and mix drug products); and equipment and utensils with visible build up and filth and lack of documentation to indicate that equipment was cleaned at appropriate.
 
The violative OTC drug products listed by FDA in its 2013 letter to Keystone included issues with mislabeled and misbranded Long Aid Medicated Hair Revitalizer Anti-Itch Formula, Ultra Glow Fade Creams, Better Braids Hair Care (shampoos, leave-in conditioner, unbraid and spray).