Red Cross fined ... AGAIN! Feb 11, 2008

FDA has fined the American Red Cross $4.6 million for the distribution of unsuitable blood products, brining penalties against the organization to more than $19 million in recent years.

The Red Cross' troubles with FDA date back over 17 years where they have committed "persistent and serious violations" of blood safety laws. Read a news account of FDA's latest action and the Red Cross' announcement. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Insights

• Should it take over 17 years to become compliant?
• What do you think is the root cause problem?
• Suppose it has anything to do with top management and the culture within the Red Cross?

Surely problems this widespread can't be blamed on "operator error." It's not because some technician made too many mistakes. In our opinion it is inexcusable for an organization that's an American icon to have this miserable track record with complying with our nation's regulations for safe and pure products.

GMP Tip
One of our basic lessons when we teach GMP is that compliance costs less than non-compliance. Here's an example you can use in your GMP training to demonstrate this principle.

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Please forward this to others in your organization who may benefit.