FDA 483 - LSNE Madison LLC - October 16, 2025

LSNE Madison, LLC dba PCI Pharma Services Company, a contract manufacturer in Madison, WI, was cited for significant deficiencies in its aseptic processing areas. The inspection revealed inadequate validation of cleaning and disinfecting processes for sterile operations, particularly concerning the Restricted Access Barrier System (RABS). Additionally, the firm failed to adhere to its established standard operating procedures for both ISO room cleaning and aseptic technique during manufacturing activities.