LSNE recently completed a successful Pre-Approval Inspection (PAI) at its facility in Bedford, NH, with no Form 483 issued, and no observations noted by the FDA.   The site received approval to manufacture a commercial drug product for U.S. distribution. The facility is dedicated to the aseptic filling and lyophilization of a product that is currently on the market.   We are very happy with the positive results of the latest FDA inspection, which is another important milestone and further adds t...