When Will They Ever Learn? - Apr 10, 2007

On March 13, Abbott Laboratories, Inc. received another Warning Letter from FDA, this time for their Diagnostics Division operation in Dallas. This follows a Consent Decree that the Abbott Diagnostics Division received from FDA in 1999 for the Abbott Park operation in Illinois.

Some of you may remember the 1960’s folk song, Where Have All the Flowers Gone?, and the chorus from that song, that goes “When Will They Ever Learn?”

Dealing with Warning Letters and Consent Decrees adds a tremendous cost burden on any company. It also adds a tremendous stress burden on the employees.

These FDA actions are best avoided simply by:

1. Keeping current on cGMP regulations.
2. Following cGMP regulations.

Training Tip
Use these two documents in your GMP training to emphasize the benefit of compliance and the perils of non-compliance. Lead a discussion on all the consequences and ramifications companies face when issued documents like these from FDA.

Read Abbott’s latest Warning Letter and the 1999 Consent Decree. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

See Mary Travers and the Kingston Trio perform Where Have All the Flowers Gone?
http://www.youtube.com/watch?v=vg8Db7VNgL0

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1097 clients since 1996

Upcoming programs:
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www.gmptrainingsystems.com/asp/lcgc_archives.asp

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www.gmptrainingsystems.com/asp/public_workshops.asp

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