Firm should adequately address plant failings during October
The US Food and Drug Administration (FDA) has informed Albany Molecular Research (AMRI) that corrective actions proposed by AMRI at its Burlington, Massachusetts aseptic finish and fill facility, once fully implemented, should adequately address the observations made by the FDA investigators in August 2010.
AMRI acquired the plant, formerly owned by Hyaluron, in June 2010 and received a warning letter from the FDA in August that year, after an inspection carried out during 2 March to 1 April 2010 identified ‘significant violations’ of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the plant.
The FDA said these violations had caused AMRI’s drug products to be adulterated and its response to the inspection, received on 21 April 2010, had lacked ‘sufficient corrective actions’.
AMRI also received a June 2011 Form 483 from the FDA at the conclusion of the inspection, notifying it of the ‘objectionable conditions’ at the plant.
The Albany, New York-based firm says it is now on track to ‘fully implement all corrective actions’ related to the 2011 Form 483 within October of this year and will present a written report on the remaining open items to the FDA following completion of these activities.
The FDA will verify AMRI’s corrective actions at the next facility inspection.
AMRI has resumed 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 chief executive, Thomas D'Ambra.
‘This is an important, positive step in resolving the issues raised by the FDA with respect to our Burlington, MA facility.
‘AMRI remains committed to ensuring the quality and safety of our products and processes at all of our locations.’