FDA EIR - Telix IsoTherapeutics Group, Inc. - February 03, 2020

An FDA inspection of IsoTherapeutics Group, LLC., located in Angleton, TX, was conducted on February 3, 2020. This inspection focused on the firm's quality systems, facilities, and equipment related to the production of R&D and clinical sterile positron emission tomography (PET) drug products, operating under the implicit regulatory framework of Current Good Manufacturing Practices (cGMP). During the inspection, no active commercial production or laboratory activities were taking place.

The inspector reviewed numerous critical quality system procedures, including those for quality unit responsibilities, customer complaints, adverse events, deviations, CAPA, change control, laboratory controls, and material handling. The report indicated no new deficiencies were found in these areas, with many procedures reviewed "without comment." Significant physical modifications to the cleanroom and laboratory areas were observed, such as installing stainless steel tables, new Biological Safety Cabinets (BSCs), and removing sinks from classified areas. These changes appear to address observations from a previous pre-approval inspection, including the modification of "previously cited wooden transfer boxes." While four change controls initiated to address prior deficiencies were reviewed, their full adequacy is pending verification during a future FDA inspection. This specific inspection did not identify new violations or mandate immediate corrective actions.