FDA 483 - Lyophilization Services of New England (LSNE) (Doing Business As PCI) - October 11, 2024

During an inspection conducted by the Food and Drug Administration from October 3-11, 2024, significant Good Manufacturing Practice (GMP) deficiencies were observed at an inspected pharmaceutical firm, requiring immediate corrective action. The inspection revealed widespread issues primarily concerning the aseptic processing of sterile drug products.Key violations included inadequate controls to prevent microbial contamination, such as uncontrolled vial transport, compromised aseptic barriers, and inconsistent procedures during critical manufacturing steps. Environmental monitoring was deemed insufficient, lacking clear instructions for personnel monitoring and proper surveillance during interventions. The firm also exhibited deficiencies in its formulation process, employing open handling methods for bulk drug substances, and had inadequate procedures for non-routine aseptic interventions, leading to exposure risks. Personnel practices, including gowning and sterile tool usage, were also criticized.Further issues involved inadequate preventative maintenance for manufacturing equipment, contributing to frequent operational disruptions. The visual inspection program for sterile products was found to be deficient, with inadequate qualification procedures and reinspection practices lacking scientific justification. Risk assessments failed to adequately address cross-contamination in a multi-product facility, and the overall facility maintenance showed issues like corrosion and broken quarantine locks. Procedural weaknesses in deviation management, including uninvestigated pest sightings and lack of timelines for initiating investigations, along with discrepancies in standard operating procedures, were also cited.These observations underscore a need for the company to implement robust corrective and preventive actions to ensure compliance with regulatory standards and the continued quality and safety of its sterile drug products.