American Red Cross - Pharma manufacturing consent decrees

Start Date: 1993; amended  2003
Financial Penalties:  $53.2 million cumulative
End Date: still pending

Violations concern the mismanagement of blood products. The most recent issues involve a failure to identify problems that occurred during collection and processing, leading to quality problems. The Red Cross has made progress in addressing the quality issues by standardizing procedures, updating its testing labs, and increasing oversight, says PRTM. But it needs to make additional progress on all issues to comply with federal regulations.

American Red Cross - Pharma manufacturing consent decrees
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