What’s Happening at LSNE®
Comprehensive FDA Inspection
LSNE recently completed a week-long, comprehensive Food and Drug Administration (FDA) Audit of its medical device manufacturing facility located in Manchester, NH. The successful completion of this audit for which no 483 citations were issued, demonstrates LSNE’s continued commitment in offering its clients quality cGMP manufacturing services.
LSNE has sustained positive corporate growth while maintaining the regulatory standards for both medical device and drug manufacturing; including the recent completion of 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.
GORE LYOGUARD Vial Isolators Displayed at Lyophilization Services of New England ‘s Facility Tour
ELKTON, Md.–(BUSINESS WIRE)–W. L. Gore & Associates, which recently launched the GORE ™ LYOGUARD ® Vial Isolator, will be displaying the new device during a facility tour at Lyophilization Services of New England (LSNE). The facility tour will take place at LSNE’s state-of-the-art contract manufacturing facility on September 9, 2009, in Bedford , New Hampshire……view PFD
Construction of Additional Manufacturing Facility in Bedford,NH
Construction has commenced on a new 40,000 square foot commercial facility with an expanded 500 sq. ft. of sterile freeze drying capacity. We plan on opening the new facility in 2009 which will allow us to immediately expand our capacity for delivering premier contract manufacturing in the U.S., specializing in liquid filling and lyophilization of medical devices and finished pharmaceuticals.