FDA 483 - SOFIE Co. dba SOFIE - October 28, 2025
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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.
ID · faa3af58-a9c5-4080-823b-203221031650