AMRI Receives FDA Notification on Proposed Corrective Actions
September 26th, 2011 // 12:17 pm @ jmpickett
AMRI today announced the receipt of a letter from U.S. Food and Drug Administration (FDA) regarding its Burlington, Massachusetts aseptic finish-and-fill facility, acquired in June 2010. The letter pertained to AMRI’s written responses to a August 2010 warning letter and a June 2011 Form 483, and stated that corrective actions proposed by AMRI, once fully implemented, should adequately address the observations made by the FDA investigators.
The Company is on track to fully implement all corrective actions related to the 2011 Form 483 within October of this year and intends to present a written report on the remaining open items to the FDA following completion of these activities. According to the FDA letter, AMRI’s corrective actions will be verified by the FDA at the next facility inspection. AMRI has resumed and is continuing manufacturing operations at the Burlington site, including GMP fills for customer projects.
“We are encouraged that the FDA believes the corrective actions we have made and are implementing should adequately address the observations raised from recent inspections,” said AMRI’s Chairman, President and CEO, Thomas E. D’Ambra, Ph.D. “This is an important, positive step in resolving the issues raised by the FDA with respect to our Burlington, MA facility. Although we believe the actions described in our submissions address the FDA observations, we are continuing to take additional actions to improve our quality, culture and performance at our Burlington operations. We are actively taking steps to rebuild Burlington’s book of business. AMRI remains committed to ensuring the quality and safety of our products and processes at all of our locations.”
