FDA 483 - CSL Plasma Inc. - April 09, 2026
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An FDA inspection of CSL Plasma Inc. in Whitestown, IN, a source plasma storage and distribution facility, revealed significant compliance issues. The firm failed to submit a biological product deviation report within 45 days for inappropriately distributed plasma. Additionally, the company did not properly label source plasma units that tested reactive for transfusion-transmitted infections or correctly relabel plasma exposed to inappropriate temperatures as "Source Plasma Salvaged."
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