American Red Cross charged $16 Billion by FDA


The American Red Cross is nation’s premier emergency response organization. It was established in 1881 and over the years it has expanded its services with the aim of preventing and relieving suffering. The American Red Cross is one of several organizations that collect and manage the nation’s blood supply. It collects and process 43% of the nation’s blood, which is about 6.5 million units of blood each year and then manufacture into about 9.5 million transfusable blood products for patients across the country. Recently The Red Cross came into the news, not for its goodwill but violating the quality control standards.

FDA Inspection report
In 2008 – 2009, FDA inspected dozen of Red Cross facilities across the nation and found that organization failed to maintain quality controls in collecting and processing blood products. FDA fined the American Red Cross $16 million on June 17, 2010, alleging that the organization had been slipshod in the collection and manufacture of blood products. The FDA acknowledged no evidence that the Red Cross violations endangered any patients.

Basis of fines
Regulators fined the organization nearly $10 million for mismanagement of blood products — including red blood cells, plasma, platelets and over $6 million for faulty manufacturing practices. The FDA has cited the Red Cross...

a dozen times already about the violations and fined the group over $21 million since 2003.

In response to the recent allegations and fines, The Red Cross said in a statement that we are fully committed to meeting all FDA standards, and we have made significant progress over the past two years in improving our regulatory compliance by implementation of system-wide changes to our operations. 98% of the violations cited by the FDA occurred before 2008, and organization has made significant improvements since then. We are disappointed that the FDA believed it necessary to fine us for prior violations dating back several years.

What threw me off was that violations were seen from American Red Cross since 2003, which still existed in 2008. It may seem harsh to American Red Cross, but I think it is necessary for FDA to keep a check on manufacturing practices of the Red Cross, given their history.

2 Responses

  1. cna training says:

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