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

Iso-Tex Diagnostics, Inc. in Alvin, TX, a radiopharmaceutical manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern a severe lack of aseptic technique and environmental control in sterile manufacturing, along with inadequate equipment maintenance, calibration, and quality control investigations. These issues indicate a high risk of product contamination and compromise of product sterility.