FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws
Here's a snippet from yesterday's press release:
The FDA announced today that the American Red Cross has been fined $16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products.What does the FDA do with all the money it receives from these fines?
Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products. However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply.
The FDA assessed fines totaling $16.18 million – $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.