Coldstream hosted FDA authorities from 8 April – 17 April 2014, at its manufacturing facility in Lexington. The site audit reviewed quality systems to ensure compliance with current Good Manufacturing Practices (cGMPs).
This inspection took the form of a Pre-Approval inspection (PAI) as part of market approval for a human pharmaceutical product. Coldstream was previously inspected by the FDA in 2009, which was also a PAI.
Coldstream president and CEO Eric W Smart noted that the company is extremely pleased with the success of this audit.
"We believe that compliance is not a destination, but a journey. As our portfolio continues to evolve toward commercial products, we recognize our responsibility to pursue the highest standards of quality. The outcome of this PAI tells me we are on the right course," Smart added.