FDA 483 - CSL Plasma, Inc.

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.