FDA 483 - Biovex, Inc. - February 13, 2015

An FDA inspection of BioVex Inc., a biological drug substance and drug product manufacturer in Woburn, MA, identified three observations. These observations primarily concern deficiencies in aseptic manufacturing practices, including improper technique in a biological safety cabinet, inadequate documentation of logbook reviews, and failure to incorporate a validated hold period into media fill studies. The findings suggest issues with manufacturing controls and adherence to established procedures.