Miami, Florida – Raidel Figueroa, the former CEO and co-owner of Pharmatech, LLC, a drug and dietary supplement manufacturer that operated in Broward County, Florida, has made his initial appearance in Fort Lauderdale federal magistrate court to face charges that he conspired to manufacture and distribute drugs outside the regulatory oversight of the FDA, to interfere with and obstruct the FDA.
The unsealed indictment charges Figueroa with conspiracy to defraud the United States, falsification of records in a federal investigation, obstruction of proceedings before an agency of the United States, and distribution of adulterated drugs in interstate commerce.
The indictment alleges the following: From 2016 to 2017, Pharmatech manufactured and distributed Diocto Liquid, a drug used to treat constipation. In July 2016, FDA initiated an inspection at Pharmatech as part of an investigation into an outbreak of Burkholderia cepacia (“B. cepacia”) infections. B. cepacia is the name for a group or “complex” of bacteria typically found in soil and water. These bacteria pose little medical risk to healthy people, but people who have certain health problems like weak immune systems or chronic lung diseases may be more susceptible to B. cepacia infections. The effects of B. cepacia can include serious respiratory infections and other types of infections. Contaminated medicines can transmit B. cepacia, and the bacteria are often resistant to common antibiotics.
At the close of the FDA’s Pharmatech inspection in August 2016, the FDA notified Figueroa that a water sample taken from Pharmatech’s system had tested positive for B. cepacia. In response, Figueroa advised the FDA that Pharmatech was re-engineering its purified water system to prevent future contaminations, according to the allegations.
In March 2017, the FDA started another inspection at Pharmatech. FDA investigators asked Figueroa to disclose all products that Pharmatech had manufactured after it resumed manufacturing. It is alleged that Figueroa lied to the FDA investigators by, among other things, knowingly excluding Diocto Liquid from its products list (even though Pharmatech shipped over 7,000 units of the drug earlier that month) and by falsely stating to the FDA that Pharmatech’s new water system had met “acceptance criteria,” which was not true.
According to the indictment, in July 2017, the CDC notified the FDA of multiple cases of 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. FDA investigated and collected bottles of Diocto Liquid from these medical centers. It is alleged that the collected bottles were from the same lot that Pharmatech distributed in March 2017 – the same one that Pharmatech failed to disclose to the FDA. Several of the bottles contained total aerobic microbial counts and total yeast and mold counts over acceptable limits and some of the bottles also tested positive for the presence of B. cepacia, says the indictment.
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, made the announcement.
The FDA Office of Criminal Investigations Miami Field Office investigated the case. Assistant U.S. Attorney Deric Zacca is prosecuting this case, with assistance from Laura Akowuah, from FDA’s Office of Chief Counsel.
An indictment contains mere allegations and defendants are presumed innocent unless and until proven guilty in a court of law.
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.
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