Former contract manufacturer CEO sentenced to prison for shipping contaminated drugs to children’s hospitals

The former CEO of a South Florida-based contract drug manufacturer has been sentenced to more than three years in federal prison over lying to the FDA and allowing contaminated products to be sent to children’s hospitals.

According to the Department of Justice, Raidel Figueroa, the former CEO and co-owner of the Davie, FL- based Pharmatech, produced and distributed the stool softener Diocto Liquid from 2016 to 2017.

Raidel Figueroa

As part of an investigation into an outbreak of infections linked to Burkholderia cepacia, or B. cepacia, the FDA inspected Pharmatech’s operations. The FDA notified Figueroa in 2016 that a sample taken from Pharmatech’s water system had tested positive for B. Cepacia but he told the FDA that Pharmatech would re-engineer its water system to prevent future contaminations.

A subsequent FDA inspection in March 2017 had asked Figueroa to disclose all products that the company had manufactured since the water system upgrade. According to the DOJ, he reportedly lied to the investigators by knowingly excluding Diocto Liquid from this list, as Pharmatech shipped over 7,000 units of the drug that month. He also told the FDA that its new water system had met “acceptable criteria” which turned out to be false.

By July 2017, an outbreak of infections in pediatric patients had been reported to the CDC at Stanford Children’s Health Lucile Packard in California and Children’s Hospital Johns Hopkins Children’s Center in Maryland. The FDA investigated the outbreak and collected bottles of the drug from these medical centers.

The FDA found that some of the bottles had high levels of bacteria, yeast and mold along with other bottles testing positive for B. cepacia. A nationwide recall of the product was eventually issued in August 2017.

In April, Figueroa was charged and eventually pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA and distributing adulterated drugs.

A paper from Hopkins researchers on the outbreak noted that the outbreak may have infected infants “via aspiration of enteral fluids, translocation across the enteric mucosa or migration into the genitourinary tract from the gastrointestinal tract, putting the most critically ill patients at highest risk.”

Pharmatech is still producing solid and liquid generic medicines, mainly vitamins and other liquids for colds, weight loss and skin care among a range of products.

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