FDA 483 - Innoveix Pharmaceuticals Inc - September 12, 2019

Innovix Pharmaceuticals Inc. in Addison, TX, was inspected regarding its production of sterile and non-sterile drug products. The inspection revealed numerous critical deficiencies in aseptic processing, environmental controls, personnel practices, and equipment sterilization, indicating a severe lack of control over sterile manufacturing operations. These issues included inadequate air quality, improper disinfection, contaminated gowning, and ineffective sterilization methods, posing significant risks to product sterility.