FDA Recall Data FY 2005

While presenting at IVT's Validation Week Annual Conference, David Markovitz, President of GMP Training Systems, took the opportunity to attend a presentation by Kristen Evans, an FDA Compliance Officer. Mr. Evans presented the Top Ten reasons for recalls overseen by the Center for Drug Evaluation and Research (CDER).

The Number One reason by a HUGE margin was cGMP Deviations.

This is more evidence that we need to do a better job in our GMP training. There were 144 recalls last year (FDA's fiscal year Oct 04- Sept 05) due to cGMP deviations (41% of all recalls). The number two reason was failed USP dissolution with 55 recalls.

To see the entire list of recall reasons, go to http://www.gmptrainingsystems.com/asp/articles.asp
Scroll down to FDA Resources.

Incidentally, after seeing David's presentation as Teddy Roosevelt - The Evolution of Food and Drug Law from the 19th Century to the 21st Century - Kristen Evans invited David to conduct this presentation for the FDA. He said, "Everyone working for FDA needs to experience your presentation."

You can learn more about this presentation at http://www.gmptrainingsystems.com/asp/evolution.asp

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