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FDA Completes Re-inspection of AMRI Facility

Issues Form 483 for three inspectional observations

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has completed a re-inspection of Albany Molecular Research, Inc.’s (AMRI) pharmaceutical manufacturing facility in Burlington, MA. Conducted from July 11, 2013 through July 18, 2013, the FDA inspected the facility, operations and quality systems, including a systematic review of corrective actions related to the previously disclosed 2011 Form 483. Following this latest inspection, the company received a Form 483 for three inspectional observations. No observations were issued following its review of the 2011 Form 483 corrective actions. 
 
The FDA’s initial warning letter was dated August 17, 2010. AMRI had acquired the facility in June 2010 and from June 8, 2011 through June 28, 2011 the FDA conducted a re-inspection of the facility and issued a Form 483 report that included seven inspectional observations.
 
The company is currently preparing a complete response to the FDA’s 2013 Form 483 with all corrective actions addressed and implemented. AMRI is continuing manufacturing operations currently ongoing at the Burlington site, including GMP operations. 
 
“We are pleased to have the FDA inspection of our Burlington operations completed,” said Thomas E. D’Ambra, Ph.D., AMRI’s president and chief executive officer. “I would like to acknowledge and thank the leadership and staff in Burlington for their hard work and dedication to quality, our customers and patient safety. Burlington will continue to operate without restriction while we await the FDA’s disposition.”

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