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FDA Lifts Warning Letter for AMRI Facility

Resolves all issues at Burlington facility

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AMRI has received a close-out letter from the U.S. FDA lifting a 2010 warning letter related to its Burlington, MA aseptic fill-and-finish facility. Thomas E. D’Ambra, Ph.D., president and chief executive officer, said, “AMRI is pleased to report that we have resolved all issues raised by the FDA related to our Burlington facility. This is consistent with feedback we have received from numerous customer quality audits of our Burlington site, confirming that the corrective actions, im...

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