FDA 483 - PhytogenX, Inc. - February 14, 2019

PhytogenX, Inc., a contract manufacturer in Morgantown, PA, was cited during an FDA inspection for failing to document the revalidation of processes. This deficiency occurred in response to significant changes and deviations, including out-of-specification results and changes in cleaning detergents. The lack of proper revalidation documentation indicates a critical gap in the firm's quality control system.