LSNE Completes FDA Inspection

LSNE has completed a comprehensive FDA audit of its medical device manufacturing facility.

LSNE has recently completed a comprehensive FDA audit of its medical device manufacturing facility in Manchester, NH. The successful completion of the week-long audit, for which no 483 citations were issued, demonstrated a quality cGMP manufacturing environment for services offered.

LSNE also recently completed an FDA Pre-Approval Inspection (PAI) and Compliance Audit for an Abbreviated New Drug Application (ANDA) for a sterile-injectable drug product at its Bedford, NH fill/finish facility.