LEXINGTON, KY., April 21, 2014 (GLOBE NEWSWIRE) -- Coldstream Laboratories, Inc., a provider of sterile drug product development and manufacturing services, has announced the completion of a successful inspection by the Food and Drug Administration (FDA). Coldstream hosted FDA authorities from April 8 – 17, 2014, at its manufacturing facility in Lexington, KY. 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.
Lonny D. White, Coldstream's Executive Director of Quality commented, "Coldstream is dedicated to developing and manufacturing high quality parenteral products that improve patient's lives. Since our last audit, we have remained focused on continuous improvement to maintain the highest standard of quality."
Coldstream's President & CEO, Eric W. Smart added, "We are 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."
Coldstream Laboratories, Inc., based in Lexington, KY, is a privately held specialty pharmaceutical contract manufacturing organization, also offering full analytical, formulation, microbiology and lyophilization development services. Coldstream specializes in the development and manufacture of highly potent compounds and operates Kentucky's only parenteral manufacturing facility.