A former owner and CEO of a Broward County drug manufacturing company who lied to the FDA and allowed contaminated products to make their way to pediatric hospitals was sentenced to 37 months in federal prison. Raidel Figueroa co-owned Pharmatech, LLC, a company that from 2016 to 2017 manufactured and distributed the laxative Diocto Liquid. In July 2016, as part of a larger investigation into an outbreak of infections linked to bacteria known as Burkholderia cepacia (“B. cepacia”), the FDA inspected Pharmatech’s operations. Typically found in water and soil, and transmissible through contaminated medications, B. cepacia 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 B. cepacia. Figueroa assured the FDA that Pharmatech would re-engineer its purified water system to prevent future contaminations. In March 2017, the FDA again inspected Pharmatech’s operations and asked Figueroa to disclose all products that the company had manufactured since its supposed water system upgrade. Figueroa lied to the FDA investigators by knowingly excluding Diocto Liquid from its products distribution list (even though Pharmatech shipped 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.
