483
CSL Plasma Inc.CSL Plasma Inc. – FDA 483, Jun 17, 2026
Record Details
An FDA inspection of CSL Plasma Inc. in Mishawaka, IN, revealed a significant issue regarding the failure to follow manufacturer instructions for quality control procedures. Specifically, staff did not properly perform quality control on a refractometer, which is a repeat observation from a previous discussion item. This indicates a moderate concern regarding adherence to established protocols for equipment usage.
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ID · e7fba662-d337-4543-86a9-c0592358b985
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