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LSNE Passes FDA Inspection

By Gil Roth | January 8, 2014

No observations at Manchester, NH site following GMP/PAI visit

The FDA recently completed an inspection of the Manchester, NH manufacturing facility of Lyophilization Services of New England (LSNE). This is the sixth successful inspection of the site, which is currently functioning as a multiproduct medical device manufacturing facility. The November 2013 inspection was a combination FDA general GMP and Pre-Approval Inspection (PAI). The inspection resulted in no Form 483 being issued, as there were no observations noted by FDA.

Matthew Halvorsen, LSNE's president and chief executive officer, commented, "We are very pleased with the result of the latest FDA inspection, which adds to our successful regulatory history. LSNE is committed to maintaining the highest level of quality across our three manufacturing sites so that we can remain a reliable partner to our clients."

This FDA inspection follows a successful inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of LSNE's 25 Commerce Drive, Bedford NH contract manufacturing facility in which LSNE received a Certificate of GMP Compliance to manufacture aseptic lyophilized drug products for use in the EU.