LSNE Contract Manufacturing (LSNE), a contract development and manufacturing organization, has successfully completed a Pre-Approval Inspection (PAI) by the U.S. FDA at its aseptic fill finish facility in León, Spain.  The inspection took place this month and LSNE was found to be compliant with no Form 483 observations issued. LSNE-León can now support commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.  “This inspection was a critical milesto...