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Pharmaceuticals / Regulatory Affairs

Judge Enters Consent Decree Against Texas Compounder

May 30, 2019

A federal judge ordered a Texas drug compounder to cease all operations after failing to respond to warnings from the FDA about insanitary conditions.

Judge Keith P. Ellison of the Southern District of Texas signed and entered the consent decree against Houston-based Pharm D Solutions and its owners, Luis and Juan De Leon. It orders them stop all sterile compounding operations and to recall all their sterile drugs.

Under the consent decree, the company won’t be able to resume business until it puts together a comprehensive quality control system and is cleared by the FDA.

“Despite previous warnings and promises to make corrections, Pharm D Solutions and its owner placed patients and their health at significant risk,” Donald D. Ashely, director of CDER’s Office of Compliance.

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