FDA 483 - Innoveix Pharmaceuticals Inc - May 27, 2021

An FDA inspection of Innoveix Pharmaceuticals Inc., a producer of sterile and non-sterile human drug products, was conducted from May 11 to May 27, 2021. The inspection resulted in nine significant observations indicating deviations from Current Good Manufacturing Practices (cGMP) for drug products, particularly in aseptic processing. Key issues included the use of non-pharmaceutical grade equipment for sterilization without adequate post-use testing, and personnel blocking first-pass air flow during sterile filling. The firm also demonstrated inadequate sterilization and cleaning processes for equipment, including using non-pharmaceutical grade detergents without validated residue removal.