Comprehensive FDA Inspection
Manchester, NH – LSNE, a premier contract manufacturer specializing in aseptic fill/finish and lyophilization of both drug and medical device products, recently completed a week-long, comprehensive Food and Drug administration (FDA) audit of its medical device manufacturing facility. 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 undergone six FDA inspections since 1999 and has manufactured approximately 6,000 lots of medical device product material following its last inspection in 2006. Matthew Halvorsen, President of LSNE, states that “the recent audit results, which did not involve any 483’s being issued, are an enormous accomplishment considering the numerous lots that have been processed in our Manchester facility in the 4 years since the last FDA inspection. This is certainly an accomplishment that we can and should take pride in as a company.”
Since its founding and initial offering of medical device contract manufacturing in 1997, LSNE has made the successful transition into also providing aseptic fill/finish contract drug manufacturing through the acquisition of state-of-the-art equipment, recruitment of qualified key personnel and continued expansion of what now includes three integrated cGMP manufacturing facilities. 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.
LSNE is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.