FDA Completes Re-inspection of AMRI Burlington Facility

Jul 22, 2013
By PharmTech Editors

In mid-July, FDA conducted a general inspection of operations and quality systems of Albany Molecular Research Inc.’s (AMRI) facility in Burlington, Mass., including a systematic review of corrective actions related to a 2011 Form 483 report to ARMI. In a press statement, the company reported that on July 18, at the conclusion of the inspection, the company received a Form 483 having three inspectional observations, which are limited in scope and nature. No observations were issued by FDA following its review of the 2011 Form 483 corrective actions.

AMRI says it is currently preparing a complete response to FDA's 2013 Form 483 with all corrective actions addressed and implemented and expects to issue such report to FDA shortly after which time FDA may choose to lift the Warning Letter. The company is continuing manufacturing operations currently ongoing at the Burlington site, including GMP operations.

The company received a Warning Letter, dated Aug. 17, 2010, from FDA in connection with FDA's inspection of the Burlington pharmaceutical manufacturing facility. After a re-inspection in June 2011, FDA issued a Form 483 report, which included seven inspectional observations. On Sept. 26, 2011, the company issued a press release announcing the receipt of a letter from FDA stating that the corrective actions proposed by the company, once fully implemented, should adequately address the observations made by FDA investigators. The letter also indicated that the company's corrective actions would be verified by FDA at the next facility inspection.

“We are pleased to have the FDA inspection of our Burlington operations completed,” said Thomas E. D’Ambra, PhD, AMRI’s president and CEO, in the company statement. “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.”