FDA 483 - Iso-Tex Diagnostics, Inc. - February 03, 2026

An FDA inspection of Iso-Tex Diagnostics, Inc. in Alvin, TX, a radiopharmaceutical manufacturer, revealed significant deficiencies in aseptic processing, facility maintenance, equipment calibration, and quality control unit responsibilities. Repeat observations highlight persistent issues with preventing microbial contamination and ensuring proper equipment performance, indicating a high severity of non-compliance. The firm failed to follow procedures for sterile drug product manufacturing and adequately investigate sterility failures.