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Pharmaceuticals / Quality / Regulatory Affairs / GMPs / Inspections and Audits

Compounder Ordered to Halt Operations

July 10, 2017
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A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations.

Medistat Rx in Foley, Ala., has been making and distributing drugs under unsanitary conditions and in violation of current good manufacturing practice requirements, the FDA said.

Drugs labeled as sterile were exposed to unsanitary conditions and may have been contaminated with filth and may be harmful if given to patients, according to the FDA. The court order also says Medistat manufactured and distributed unapproved drugs and improperly labeled drugs.

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