Drugs

Former Pharmatech CEO Charged

The Department of Justice says that Raidel Figueroa, the former CEO and co-founder of Pharmatech, a drug and dietary supplement manufacturer that operated in Broward County, FL, has been charged with conspiring to manufacture and distribute drugs outside FDA regulatory oversight and to interfere with and obstruct FDA. A department statement says an unsealed indictment charges Figueroa with conspiracy to defraud the United States, falsification of records in a federal investigation, obstruction of proceedings before a U.S. agency, and distribution of adulterated drugs.

The case dates to a 7/2016 FDA inspection at Pharmatech as part of an investigation into an outbreak of Burkholderia cepacia infections. Figueroa was notified that a water sample taken as part of the inspection tested positive for B. cepacia.

Although Figueroa told the agency that the company purified water system was being reengineered to prevent future contamination, the indictment says he lied during a 3/2017 inspection about the identity of products being manufactured and about the status of the water system.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome