FDA 483 - Sofie Co - July 12, 2024

During an FDA inspection from July 9-12, 2024, Sofie Co. dba Sofie, a Human PET Drug Manufacturer in Romeoville, IL, received a Form FDA 483 detailing significant observations. The inspection revealed deficiencies in equipment cleaning procedures and production and process controls, indicating potential non-compliance with manufacturing standards. Specifically, the company did not adequately implement procedures to ensure all equipment, particularly laminar flow hoods, were properly cleaned, with the ceiling and outer lip of a hood being missed before product preparation. The established cleaning procedure (SOP QC.0018) lacked explicit instructions for cleaning the laminar flow hood ceiling, and wet contact times for disinfectants were not consistently met or documented. Furthermore, Sofie Co. lacked sufficient controls to ensure consistent PET drug production. Issues included the absence of scientific justification for environmental monitoring settle plate placement outside the critical work zone and a critical aseptic processing lapse where an operator failed to change gloves or disinfect hands after touching a non-sterile chair before beginning work in an ISO 5 Laminar Flow Hood. These observations highlight the need for immediate corrective actions to ensure product quality and purity, aligning with the Federal Food, Drug, and Cosmetic Act.