FDA 483 - Lyophilization Services of New England Inc. - July 31, 2013

An FDA inspection of Lyophilization Services of New England Inc. in Bedford, NH, a sterile product manufacturer, revealed significant deficiencies in quality control and aseptic processing. The firm failed to thoroughly investigate foreign material contamination, including black spots and protein-like particulates, in sterile drug product vials. Additional concerns included inadequate container integrity studies, deficient in-process controls, insufficient sterilization validation, and poor environmental monitoring practices in aseptic areas, indicating a high risk to product quality and sterility.