Albany Molecular Research ($AMRI) has been whittling down the FDA issues at a plant in Burlington, MA, for several years, and Monday said it just about has them all resolved. It has turned the plant into a key asset and may soon see a three-year-old warning letter closed out.
FDA inspectors were in the plant earlier this month, and they checked on its quality and did a "systematic review of corrective actions" related to a 2011 Form 483, the company said. Inspectors left a new Form 483 with three observations, none that were repeats from earlier problems, which includes the warning letter the company got in 2010 shortly after it acquired the plant.
AMRI has already jumped on the FDA concerns, and it is preparing its response and is hopeful the FDA will soon lift the warning letter. "We are pleased to have the FDA inspection of our Burlington operations completed," AMRI CEO Thomas D'Ambra said. He said the plant will continue to operate without any limits while AMRI awaits the "FDA's disposition."
AMRI picked up the plant in 2010 with the acquisition of Hyaluron. AMRI liked that it specialized in aseptic fill services for liquid and lyophilized products, but the FDA criticized the plant for failing to thoroughly investigate particulate contamination in several lots of injectable drugs. AMRI brought in new management for the plant and started in on fixes. In February, AMRI CFO Michael Nolan told investors that the improvements at the Burlington facility had turned the operation around and that the one-time "money pit" would help AMRI bump up large-scale manufacturing this year.
- here's the press release