Innoveix Pharmaceuticals Inc – FDA 483, May 27, 2021

Innoveix Pharmaceuticals Inc. in Addison, TX, was inspected from May 11-27, 2021, and received a Form FDA 483 with nine observations. The inspection revealed significant deficiencies in aseptic processing, sterilization, and cleaning procedures for sterile injectable drug products, including the use of non-pharmaceutical grade materials and inadequate environmental controls. These issues indicate a high risk of product contamination and compromise of sterility assurance.