The U.S. Food and Drug Administration announced Thursday that it fined the American Red Cross $16.2 million for prior failures to comply with federal laws and regulations related to the collection and manufacture of blood products.
Last year, the federal drug agency notified the Red Cross that inspections in 2008 and 2009 revealed it had failed to identify and investigate problems in its processes for making blood products that include red cells, plasma and platelets. The FDA inspectors examined 12 Red Cross facilities, including the one Penn Jersey Region facility at 700 Spring Garden Street in Philadelphia in July 2008.
Despite the large fine - $9.8 million for violations related to mismanagement of blood products and $6.4 million for violations of good manufacturing processes – the FDA said it had found no evidence that the problems “endangered any patients.”
Moreover, the FDA stated, “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.”
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