American Red Cross Statement on U.S. Food and Drug Administration (FDA) Fines

Jun 17, 2010, 17:54 ET from American Red Cross

WASHINGTON, June 17 /PRNewswire-USNewswire/ -- The American Red Cross issued the following statement regarding today's fines assessed by the Food and Drug Administration.



"The American Red Cross and the Food and Drug Administration share a common goal of the safest blood supply possible for this country.  We appreciate the fact that the FDA has recognized that the Red Cross is making progress in improving compliance, but are disappointed that the FDA believed it necessary to fine us for prior violations dating back several years. The FDA also acknowledged no evidence that the Red Cross violations endangered any patients.  

"The Red Cross is fully committed to meeting all FDA standards, and we have made significant progress over the past two years in improving our regulatory compliance by our implementation of system-wide changes to our operations.

"The fines announced today relate to Adverse Determination Letters sent by the FDA to the Red Cross in October. It's important to understand that many of the incidents cited by the FDA in the October 2009 notification occurred prior to the improvements made by the Red Cross. In fact, 98 percent of the events identified by the FDA took place before 2008 and the recalls cited represent 0.0775 percent of our blood products, which is less than one-tenth of one percent of our total number of blood products produced.

"The Red Cross collects and processes approximately 43 percent of the nation's blood supply, about 6.5 million units of blood each year. These units of blood are then manufactured into about 9.5 million transfusable blood products for patients across the country.

"People should not hesitate to give or receive blood. Giving blood saves lives, and we appreciate all those who help others in need by giving blood."

SOURCE American Red Cross