AMRI receives a Form 483 from the FDA for Burlington pharmaceutical manufacturing facility

Jul 23 2013

As previously disclosed, Albany Molecular Research, Inc. ("AMRI" or "the "Company") (NASDAQ: AMRI) received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA's inspection of the Company's pharmaceutical manufacturing facility located in Burlington, Massachusetts. The Company acquired the facility on June 14, 2010. From June 8, 2011 through June 28, 2011, the FDA conducted a re-inspection of the Company's Burlington facility. On June 28, 2011, the FDA issued a Form 483 report to the Company, which included seven inspectional observations (the "2011 Form 483").

On September 26, 2011, the Company issued a press release announcing the receipt of a letter from the FDA stating that corrective actions proposed by the Company, once fully implemented, should adequately address the observations made by the FDA investigators. The letter also indicated that the Company's corrective actions would be verified by the FDA at the next facility inspection.

From July 11, 2013 through July 18, 2013, the FDA conducted a general inspection of the company's Burlington facility, operations and quality systems, including a systematic review of corrective actions related to the 2011 Form 483. On July 18, 2013, at the conclusion of the inspection, the Company received a Form 483 having three inspectional observations which are limited in scope and nature (the "2013 Form 483"). No observations were issued by the FDA following their review of the 2011 Form 483 corrective actions.  

The Company is currently preparing a complete response to the FDA's 2013 Form 483 with all corrective actions addressed and implemented and expects to issue such report to the FDA shortly after which time the FDA may choose to lift the Warning Letter. The Company 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 CEO. "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."