The order prohibits the compounder from making any sterile drugs until it completes corrective actions.
The agency alleges the compounding pharmacy manufactured and distributed drugs that were tainted because the drugs were made in unsanitary conditions.
According to the FDA, Pharm D Solutions continued to produce the drugs despite several warnings from the agency.
“Despite previous warnings and promises to make corrections, Pharm D Solutions and its owners placed patients and their health at significant risk. Compounders must follow quality manufacturing practices to ensure consumers are not exposed to potentially harmful drugs,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
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Mallinckrodt to spin off generics unit
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