Marc Chatoff and Kurt Radke, Illicit Drug Manufacturing, Vermont 2023

Edge Pharm Inc, a compounding pharmacy in Colchester, Vermont, has been permanently enjoined from distributing drugs not made in compliance with the Federal Food, Drug and Cosmetic Act (FDCA).

A federal court has entered a permanent injunction against Edge Pharm Inc, and its owners and operators Marc Chatoff and Kurt Radke, for violating the FDCA by manufacturing and distributing adulterated and misbranded drugs.

The defendants were accused of causing drugs to become adulterated and misbranded while held for sale, and introducing new unapproved drugs into interstate commerce.

According to the complaint filed May 20, Edge Pharm Inc manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility.

The U.S. Food and Drug Administration (FDA) 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.

“Compounding pharmacies must ensure that their products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton. “The department will continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”

The defendants have agreed to settle the suit and be bound by a consent decree of permanent injunction.

Under the consent decree, the defendants are required to stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to the FDA that they will comply with federal law.

**MANDATORY FACTS**

**Defendant/Respondent:** Edge Pharm Inc, Marc Chatoff, Kurt Radke

**Exact Criminal Charges:** Manufacturing and distributing adulterated and misbranded drugs, causing drugs to become adulterated and misbranded while held for sale, and introducing new unapproved drugs into interstate commerce.

**City and State:** Colchester, Vermont

**Exact Date:** May 20

**Sentence/Outcome:** Permanent injunction and consent decree

**Dollar Amounts:** None mentioned in the source

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