FDA 483 - Galaxy Medical Products, LLC - April 28, 2026

An FDA inspection of Galaxy Medical Products LLC, a medical gas manufacturer in Medina, OH, revealed a significant quality control deficiency. The firm's quality control unit lacked the authority to properly review production records and investigate errors, specifically failing to document and investigate the use of an out-of-calibration thermometer during the filling of medical gas cylinders, potentially impacting product quality.