Frontida BioPharm announced the Food and Drug Administration (FDA) issued a closure letter for its Philadelphia manufacturing site. The closure letter was received eight months after the FDA issued a Warning Letter to Frontida based on an FDA inspection of the site occurring between June 15 and July 17, 2015, prior to Frontida’s purchase and operation of the facility.
Frontida also announces the launch of their operations expansion initiatives. Since acquiring the facilities on June 3, 2016, Frontida retained 155 positions at the existing sites and added more than 65 quality and scientific professionals. With the implementation of Quality System improvements across the organization, Frontida plans to hire an additional 40-50 personnel in the next 6 months as it begins to launch new products in its Philadelphia and Aurora facilities.
“Philadelphia is a great region for Frontida to build our organization due to its strong talent pool and pharmaceutical research heritage. Over the past 11 months, Frontida has built a strong foundation by providing new leadership, expanding our manufacturing, QC, and R&D work force, and improving operational and quality systems,” Dr. Song Li, CEO of Frontida BioPharm said. “We are continuing to expand our capabilities with additional manufacturing and laboratory personnel, equipment, and capital investments. The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market.”