Health

Drug company CEO pleads guilty to selling tainted medicine

FORT LAUDERDALE, Fla. — A former proprietor and CEO of a South Florida drug manufacturing company has been sentenced to three years and one month in federal jail for mendacity to the U.S. Food and Drug Administration and permitting contaminated medicine to go to pediatric hospitals.

Raidel Figueroa was sentenced Wednesday in Fort Lauderdale federal courtroom, data present. He pleaded guilty in June to conspiring to defraud the FDA, falsifying data in an FDA investigation, obstructing proceedings earlier than the FDA and distributing adulterated medication.

Figueroa had beforehand been a co-owner of PharmaTech LLC, which manufactured and distributed the laxative Diocto Liquid from 2016 to 2017, in accordance to courtroom data.

The FDA inspected the company’s operations in July 2016 as half of a bigger investigation into an outbreak of infections linked to micro organism often known as Burkholderia cepacia. The micro organism is often present in water and soil and may lead to respiratory and different infections for individuals with weak immune programs, persistent lung illness and different circumstances.

The FDA notified Figueroa in August 2016 {that a} pattern taken from Pharmatech’s water system had examined optimistic for the micro organism. Investigators mentioned Figueroa assured the FDA that Pharmatech would re-engineer its purified water system to stop future contaminations.

During a March 2017 inspection, Figueroa lied to FDA investigators by knowingly excluding Diocto Liquid from its merchandise distribution listing, regardless of delivery over 7,000 models 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 mentioned.

The Centers for Disease Control and Prevention notified the FDA in July 2017 of bacterial infections in pediatric sufferers 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 quantities of micro organism, yeast and mould, officers mentioned. Some bottles examined optimistic for Burkholderia cepacia. FDA investigators decided the bottles had come from Pharmatech in March 2017, which Figueroa knowingly failed to disclose.

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