483
Iso-Tex Diagnostics, Inc.FDA 483 - Iso-Tex Diagnostics, Inc. - January 31, 2018
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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.
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ID · 540c0280-7b11-4bde-98a4-d92afe29fa0e