In August 2016, the FDA informed Figueroa that a water sample obtained from PharmaTech’s system was contaminated with B. cepacia. In response, he told the agency that his company was re-engineering its purified water system to prevent contaminations in the future.
The FDA conducted another inspection at PharmaTech in March 2017. The agency’s investigators requested Figueroa to disclose all products manufactured by the pharmaceutical company after resuming its operation. He allegedly falsely told the agency’s investigators that its new water system met “acceptance criteria. He also allegedly knowingly excluded Dicto Liquid from the pharmaetical company’s product list.
In July 2017, the FDA started investigating Diocto Liquid after receiving a notification from the Centers for Disease and Control Prevention (CDC) regarding multiple cases of B. cepacia infections in pediatric patients at Stanford Children’s Health Lucile Packard Children’s Hospital in Palo Alto, California and Johns Hopkins Children’s Center in Baltimore, Maryland.
