FORT LAUDERDALE, Fla. — A former owner and CEO of a South Florida drug manufacturing company has been sentenced to three years and one month in federal prison for lying to the U.S. Food and Drug Administration and allowing contaminated medicine to go to pediatric hospitals.
Raidel Figueroa was sentenced Wednesday in Fort Lauderdale federal court, records show. He pleaded guilty in June to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA and distributing adulterated drugs.
Figueroa had previously been a co-owner of PharmaTech LLC, which manufactured and distributed the laxative Diocto Liquid from 2016 to 2017, according to court records.
The FDA inspected the company’s operations in July 2016 as part of a larger investigation into an outbreak of infections linked to bacteria known as Burkholderia cepacia. The bacteria is typically found in water and soil and can lead to respiratory and other infections for people with weak immune systems, chronic lung disease and other conditions.
The FDA notified Figueroa in August 2016 that a sample taken from Pharmatech’s water system had tested positive for the bacteria. Investigators said Figueroa assured the FDA that Pharmatech would re-engineer its purified water system to prevent future contaminations.
During a March 2017 inspection, Figueroa lied to FDA investigators by knowingly excluding Diocto Liquid from its products distribution list, despite shipping over 7,000 units of the drug earlier that month, and by telling the FDA that Pharmatech’s new water system had met “acceptance criteria,” which was not true, prosecutors said.
The Centers for Disease Control and Prevention notified the FDA in July 2017 of bacterial 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. Bottles of Diocto Liquid collected from the hospitals contained unacceptable amounts of bacteria, yeast and mold, officials said. Some bottles tested positive for Burkholderia cepacia. FDA investigators determined the bottles had come from Pharmatech in March 2017, which Figueroa knowingly failed to disclose.