Department of Justice
Southern District of FLorida
FOR IMMEDIATE RELEASE
Thursday, September 1, 2022
Miami, Florida – 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 yesterday 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.
In July 2017, the CDC notified the FDA of multiple 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. The FDA investigated, collecting bottles of Diocto Liquid from these medical centers. Several of the bottles contained unacceptable amounts of bacteria, yeast, and mold. Some bottles tested positive for B. cepacia. The FDA’s investigation revealed that Pharmatech had distributed those same bottles in March 2017 – something that Figueroa knowingly failed to disclose to the FDA.
In June, Raidel pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA, and distributing adulterated drugs.
Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, and Justin C. Fielder, Special Agent in Charge, Food and Drug Administration (FDA) Office of Criminal Investigations Miami Field Office, announced the sentence imposed by Senior United States District Judge James I. Cohn.
The FDA Office of Criminal Investigations, Miami Field Office investigated the case. Assistant U.S. Attorney Deric Zacca is prosecuting this case, with the assistance of Laura Akowuah, from FDA’s Office of Chief Counsel.
Related court documents and information may be found on the website of the District Court for the Southern District of Florida at www.flsd.uscourts.gov or at http://pacer.flsd.uscourts.gov, under case number 22-cr-60033.
USAO - Florida, Southern
Public Affairs Unit U.S. Attorney’s Office Southern District of Florida USAFLS.News@usdoj.gov