LSNE Passes FDA PAI InspectionBy
Lyophilization Services of New England, Inc. (LSNE) reports that following a pre-approval inspection (PAI) by the US Food and Drug Administration in November 2014, its manufacturing site in Bedhford, New Hampshire, has received approval to manufacture commercial drug product for US distribution. The PAI resulted in no Form 483 being issued, as there were no observations noted by the FDA. This facility is dedicated to the aseptic filling and lyophilization of a product that is currently on the market.
LSNE is a contract manufacturer with three GMP manufacturing sites in New England. LSNE added additional capabilities across its three sites in 2014 and, it plans to continue expanding in 2015. The 2015 master plan includes expansion of quality-control analytical testing capabilities, ICH stability chambers, additional complex/potent compound handling capabilities, as well as increased manufacturing capacity.