FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - June 10, 2026

An FDA inspection of Lyophilization Services of New England, Inc. dba PCI Pharma Services in Bedford, NH, revealed six observations related to the manufacture of sterile drug products. The findings highlight significant deficiencies in aseptic processing controls, environmental and personnel monitoring, equipment design and maintenance, and facility repair. These issues collectively indicate a lack of adequate controls to prevent microbiological contamination and ensure drug product quality.