DPT Laboratories, a contract development and manufacturing organization (CDMO), received notification from the U.S. Food and Drug Administration (FDA) on February 19, 2013 that signaled the completion of their evaluation of DPT’s corrective actions taken at its Lakewood, NJ facility in response to the warning letter received on August 27, 2012. In addition, this letter communicated that in the view of the FDA, the Lakewood site is compliant with FDA regulations.
DPT worked diligently to ensure all violations noted in the warning letter were adequately addressed and continues to invest significant resources into ensuring that its compliance is world class. The commitment and effort of the team resulted in this issue being closed out in approximately 4.5 months.
“We are pleased to have this issue behind us and appreciate the confidence our new and existing customers demonstrated in us during this time,” said Eugene Ciolfi, DPT Vice President and General Manager. “I am excited and optimistic about the opportunities ahead of us in 2013.”