FDA 483 - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - April 15, 2021

An FDA inspection of Lyophilization Services of New England, Inc. in Bedford, NH, a drug product manufacturer, revealed significant deficiencies in manufacturing process control and quality system documentation. Observations included inadequate control over the vial capping process, a lack of requalification for critical worst-case equipment, and a deficient standard operating procedure for aseptic process validation. These issues indicate a need for improved control over manufacturing operations and updated procedural guidelines.