SOFIE Co. dba SOFIE – FDA 483, Oct 28, 2025

SOFIE Co. dba SOFIE in Houston, TX, a PET drug manufacturer, was cited for four observations during an FDA inspection. The findings indicate significant deficiencies in facility design for contamination prevention, inadequate production and process controls, and a failure to properly investigate environmental monitoring out-of-specification results. Additionally, the firm lacked adequately trained personnel for aseptic operations, highlighting a systemic issue in maintaining a state of control.