U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought the action on behalf of the Food and Drug Administration (FDA).
The consent decree prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements.
“Injectable drugs must be produced under sterile conditions,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Specialty Compounding’s manufacturing practices and products put patients at risk. This consent decree reflects the FDA’s commitment to taking enforcement action against companies that fail to produce sterile drugs in compliance with the law.”
In August 2013, the FDA received reports from two Texas hospitals that 17 patients had developed bacterial bloodstream infections after receiving an infusion of the drug calcium gluconate manufactured by Specialty Compounding. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since Feb. 1, 2013. The company and its owners also committed to implementing corrective actions before resuming production of sterile drugs.
The FDA inspected Specialty Compounding’s Cedar Park facility in August and September 2013 and found insanitary conditions and numerous violations of the current good manufacturing practice (CGMP) requirements for drug products. Among other observations, FDA investigators found that the company did not adequately clean and disinfect equipment and rooms, and did not have adequate laboratory testing for its injectable drugs. In addition, the FDA’s laboratory analyses found bacterial contamination in some of the company’s injectable drugs.