FDA 483 - Sofie Co - July 09, 2024

Sofie Co. dba Sofie, a human PET drug manufacturer in Romeoville, IL, was cited for significant deficiencies in equipment cleaning procedures and production/process controls during an FDA inspection. Observations included inadequate cleaning of laminar flow hoods, failure to adhere to disinfectant contact times, and critical aseptic processing breaches by personnel. These issues indicate a lack of control over the manufacturing environment and processes, potentially impacting drug quality and purity.