483
CSL Plasma Inc.CSL Plasma Inc. – FDA 483, Apr 9, 2026
Record Details
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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- Detroit District Office
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ID · baf9b30b-b26a-4e5a-a400-113dcd29fd4f
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