GMP Tips - American Red Cross Fined $4.2 Million - Sept 10, 2006

FDA announced on Sept 8 that the American Red Cross is being fined $4.2 million for failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products. The violations include breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols.

Since entry of the 2003 Consent Decree and prior to this action, FDA has issued the American Red Cross seven similar letters and assessed a total of $5.7 million in penalties.

Some organizations get it, and some don't.
Don't you think investing in effective GMP training could have prevented this?

GMP Training Systems, Inc. could have conducted the training for American Red Cross for less than $4.2 million. We could have charged them $3 million, and saved them $1.2 million. What a deal! Just kidding - we have reasonable rates - just call us to find out how we can help you prevent situations like this one.

Read FDA's Press Release explaining the reasons for this action. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to the entry labeled American Red Cross fined by FDA.

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www.GMPTrainingSystems.com
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