FDA 483 - PhytogenX, Inc. - March 27, 2025

Phytogenx, Inc. in Morgantown, PA, was inspected and received a Form 483 with two observations related to quality control. The inspection revealed deficiencies in component testing, specifically for glycerin, and inadequate finished product microbial testing for non-sterile aqueous drug products. These issues indicate potential risks to product quality and patient safety.