Telix IsoTherapeutics Group, Inc. – FDA 483, Jul 31, 2025

Telix Isotherapeutics Group, Inc. in Angleton, TX, was inspected by the FDA, resulting in 10 observations. The inspection revealed significant deficiencies in facility maintenance, aseptic processing controls, quality unit procedures, and data integrity. These issues indicate a lack of adherence to cGMP regulations, potentially impacting the sterility and quality of their drug products and veterinary devices.