Source: United States Department of Justice News
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, pled guilty to conspiring to defraud the FDA, falsifying records in an FDA investigation, obstructing proceedings before the FDA, and distributing adulterated drugs in Fort Lauderdale federal court yesterday.
Court documents show that from at least 2016 through at least March 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 inspection in August of 2016, the FDA notified Figueroa that a water sample it had taken from Pharmatech’s water system had tested positive for the presence of B. cepacia. In response, Figueroa advised the FDA that Pharmatech was re-engineering its purified water system to prevent future contaminations.
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. 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.
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. The collected bottles were from the same lot that Pharmatech distributed in March 2017 – the same lot that Pharmatech failed to disclose to the FDA. Several of the bottles contained total aerobic microbial counts and total yeast and mold counts in excess of acceptable limits and some of the bottles also tested positive for the presence of B. cepacia.
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.
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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