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FDA Takes Enforcement Action at Genzyme Plant

The FDA has notified Genzyme Corp. that it intends to take enforcement action to ensure that products manufactured at the company’s Allston plant are made in compliance with GMP regulations.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has notified Genzyme Corp. that it intends to take enforcement action to ensure that products manufactured at the company’s Allston plant are made in compliance with GMP regulations. This action will likely result in a consent decree, under which a third party will inspect and review the plant’s operation for an extended period in order to certify compliance with FDA regulations. Under a consent decree, Genzyme would be required to make payments to the government and could incur other co...

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