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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, improvements and upgrades taken at this facility provide even stronger support for our growing customer list and meet the high standards necessary to successfully operate an injectable dosage form operation. I would like to acknowledge and thank the many AMRI colleagues who have worked tirelessly and diligently to achieve this important milestone.”
 
The Burlington facility provides cGMP manufacturing and sterile filling of parenteral drugs using specialized technologies including lyophilization and Bubble-Free Filling. AMRI Burlington supports preclinical through commercial scale production of liquid-filled and lyophilized parenterals for both small molecule drug products as well as biologics, from clinical to commercial scale.
 
In June 2013, AMRI Burlington received an expanded registration to handle Schedule II and IIN controlled substances, in addition to its Schedule III, IIIN, IV, and V controlled substances. The addition of Schedule II compounds allows Burlington to perform controlled substance work, both in the lab and on the engineering/production side.

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