FDA 483 - Telix IsoTherapeutics Group, Inc. - July 31, 2025

Telix Isotherapeutics Group, Inc. in Angleton, TX, received a Form 483 with 10 observations following an FDA inspection. The findings highlight significant deficiencies in facility maintenance, aseptic processing controls, quality unit responsibilities, and data integrity. These issues indicate a lack of adherence to cGMP requirements, potentially impacting the quality and sterility of drug products.