FDA 483 - LSNE Madison LLC - October 11, 2024

The FDA inspection of Lyophilization Services of New England (LSNE) (Doing Business As PCI) in Madison, WI, revealed significant deficiencies in aseptic processing, environmental monitoring, and contamination control for sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbial contamination, maintain equipment, and ensure product quality. These issues indicate a high severity of non-compliance across multiple critical manufacturing areas.