483
CSL Plasma, Inc.FDA 483 - CSL Plasma, Inc.
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Record Details
An FDA inspection of CSL Plasma, Inc. in Indianapolis, IN, a source plasma collection facility, revealed a significant compliance issue. The firm failed to perform Relevant Transfusion Transmitted Infections (RTTIs) testing on all donations, specifically cancelling test orders for low-volume units that applicable regulations require to be tested. This indicates a failure to follow their own SOP and regulatory requirements for ensuring product safety.
- Company
- CSL Plasma, Inc.
- Product Type
- Biologics
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ID · 68f132d2-b666-4798-933e-7af301e5c05d