FDA 483 - Iso-Tex Diagnostics, Inc. - February 10, 2023

Iso-Tex Diagnostics, Inc., a radiopharmaceutical manufacturer in Alvin, TX, was cited for significant deficiencies during an FDA inspection. The observations primarily concern poor aseptic processing practices, inadequate environmental monitoring, and facility design issues that compromise sterility. These issues indicate a serious lack of control over the manufacturing environment and processes for sterile drug products.