FDA 483 - Biovex, Inc. - September 27, 2019

An FDA inspection of BioVex Incorporated in Woburn, MA, a biological drug substance and drug product manufacturer, identified significant deficiencies in their investigation processes. The firm failed to adequately investigate nonconformances related to misaligned crimp caps, microbial contamination in processing columns, and environmental monitoring, leading to potential product quality and safety concerns. These issues indicate a breakdown in the firm's quality unit and its ability to ensure product integrity.