FDA 483 - Iso-Tex Diagnostics, Inc. - January 31, 2018

An FDA inspection of Iso-Tex Diagnostics, Inc. in Alvin, TX, a manufacturer of sterile radiopharmaceutical injectable drugs, revealed a significant deficiency in aseptic processing controls. The firm failed to conduct dynamic smoke studies in its clean rooms, which poses a risk to the sterility of its injectable drug products.