FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - January 29, 2014

An FDA inspection of Lyophilization Services of New England, Inc. in Bedford, NH, revealed significant deficiencies in quality unit oversight, environmental monitoring, and validation practices. The firm failed to justify critical changes to manufacturing procedures, adequately investigate mold contamination, and properly validate equipment and cleaning processes. These issues indicate a lack of control over their lyophilization operations, potentially impacting product quality and safety.