FDA warns Celltrion over its Incheon plant
Executive Summary
Celltrion has received a warning letter from the US Food and Drug Administration (FDA) following an inspection of its manufacturing facility in Incheon, South Korea, carried out in May and June 2017. “The letter raises issues related to certain manufacturing processes at the facility,” Celltrion said. “We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with the highest priority.”