483
CSL Plasma IncFDA 483 - CSL Plasma Inc - March 22, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of CSL Plasma, Inc. in Las Vegas, Nevada, revealed a critical deficiency in donor notification procedures. The firm failed to inform donors of reactive test results for relevant transfusion-transmitted infections, including positive HIV screening and confirmatory results, which led to donor deferral. This indicates a serious non-compliance with established protocols for unsuitable events management.
- Person
Open in Dashboard
ID · d0d28a4d-c691-4a20-8cfb-65734e1cfe1c