FDA Seizes Pumps

Here's an incident you can use to reinforce the need to comply with GMP. This case demonstrates the power FDA has and their willingness to use it.

THE CASE
On October 12, 2005, a US District Court, working with the FDA, issued a warrant for seizure of infusion pumps manufactured by Baxter Healthcare Corporation. Four thousand pumps were seized by the US Marshals Service from a Baxter warehouse, and 135 pumps were seized from a distributor's warehouse.

FDA inspections revealed that the firm has continually failed to follow medical device manufacturing requirements in the manufacture of these pumps. Baxter was previously issued Warning Letters outlining the violations and was given an opportunity to correct the violations, but failed to take appropriate actions.

"This case demonstrates that the FDA will take the necessary steps to protect America 's public health," said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs. "Today's notification shows our commitment to informing the public about important safety issues."

Read FDA's Press Release at http://www.gmptrainingsystems.com/asp/articles.asp

What might be the business consequences this company faces as a result of this action?

This is a good question to use when using this case in a GMP training session. Place people in small groups and have them discuss this question for 5 minutes or so. Then debrief each group - have them share their findings - with the entire class.

The key wrap-up question then becomes:
"Which is easier and less costly? Dealing with the issues of the product seizure, or complying with GMP in the first place?"

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our next two-day public seminar, Fundamentals of GMP/QSR is scheduled for November 16-17 in Anaheim, CA. Ideal for people new to the industry.