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LSNE Passes FDA Inspection

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

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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&#82...

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