FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - December 07, 2018

An FDA inspection of Lyophilization Services of New England, Inc. in Bedford, NH, a pharmaceutical manufacturer, revealed significant deficiencies across multiple quality systems. The firm failed to adequately manage quality processes, maintain appropriate equipment design and sanitization, thoroughly investigate product complaints, and establish procedures to prevent microbiological contamination of sterile drug products. These issues indicate a systemic breakdown in quality control and manufacturing practices.