A Vermont compounding pharmacy has agreed to stop producing adulterated and misbranded drugs

A Vermont compounding pharmacy has agreed to stop producing adulterated and misbranded drugs, the U.S. Justice Department said Monday. Edge Pharma of Colchester and its owners and operators signed a consent decree with the Justice Department on Friday that requires Edge Pharma Inc. of Colchester to take specific remedial measures to ensure its products are safe and demonstrate to the Food and Drug Administration that they will comply with federal law. In a complaint filed last month, the United States alleged that U.S. Food and Drug Administration inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients. In a Monday statement, David Lazarus, one of the attorneys for Edge, said that on April 27, a few weeks before the planned re-opening of the company, Edge Pharma voluntarily agreed to the consent decree, but neither admitted nor denied any of the allegations made by the Justice Department or the FDA. Edge Pharma has been cooperative with the FDA and the Justice Department.

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https://www.wcax.com/2022/06/13/vermont-compounding-pharmacy-agrees-stop-distributing-some-drugs/