24 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: FDA has issued warning letter to Albany Molecular Research (AMRI) in connection with an inspection of the company's pharmaceutical manufacturing facility located in Burlington, Massachusetts, US, conducted during 2010. AMRI 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.
On September 26, 2011, the firm received 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 firm'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. 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 firm 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 Dr Thomas E D'Ambra, 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."