The compounding center, along with its CEO Shaun Riney and director of quality Jasen Lavoie, entered a consent decree Dec. 19 in which they are prohibited from manufacturing and distributing drugs that aren’t FDA compliant.
Among Qualgen’s repertoire of drugs are hormone replacement therapies, including testosterone, estradiol and testosterone/anastrozole products. The lawsuit claims the defendants violated the Federal Food, Drug, and Cosmetic Act by “failing to follow written procedures applicable to the quality control unit, failing to reject drug products that did not meet specifications and failing to follow appropriate procedures in handling complaints about its drug products,” according to the Justice Department.
The complaint also alleged that many violations from the compounding facility’s five FDA inspections — which happened in 2015, 2017, 2018, 2021 and 2022 — were repeat violations.
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