Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services – FDA 483, Nov 5, 2020

An FDA inspection of Lyophilization Services of New England, Inc. in Bedford, NH, a drug product manufacturer, identified two observations. The inspection found that the non-aseptic manufacturing facility was not adequately maintained, with issues such as deteriorated sealant, unseated light fixtures, and chipping paint. Additionally, a standard operating procedure for manual cleaning of process equipment was deemed inadequate as it did not accurately reflect common manufacturing practices.