FDA Mix-up & a Costly Lesson for Baxter - Feb 25, 2008

Last week Baxter International, Inc. announced that it had temporarily suspended production of heparin because of about 350 reactions potentially tied to the drug, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery.

The Chinese factory (Baxter's supplier) involved in the production of possibly tainted blood-thinning drugs for export to America was not inspected by the U.S. FDA because of a paperwork error in which Washington regulators confused the factory's name with another that already had U.S. approval, the FDA said Monday.

An FDA spokeswoman said the plant making the active ingredient for the drug heparin "was supposed to be inspected" but "due to human error, and inadequate information technology systems, a pre-approval inspection, which would normally be conducted, was not."

Baxter CEO Robert Parkinson said he was unaware the Food and Drug Administration had not inspected a suspect supplier in China. "It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Note: Shouldn’t Baxter be conducting audits of their suppliers?

A Baxter spokeswoman confirmed that the company gets the active pharmaceutical ingredient for its heparin from a U.S. supplier that operates a plant in China. She said Baxter has been working with the U.S. supplier for 20 years, and the supplier has made the heparin ingredient for three decades. Baxter has only sold heparin since late 2002, when it bought a unit of Wyeth.

GMP Tip

Through an acquisition, Baxter picks up a new division to produce heparin. Supplier audits are an integral part of GMP. But somehow conducting a thorough inspection and audit of the supply chain for this product slipped through the corporate crack. And then it slips through a crack in FDA’s bureaucracy.

Next thing you know, 350 patient reactions and four deaths. Who wants to bet that Congress will be conducting more hearings about the competence of FDA?

Read the news story on how FDA “thought” they had inspected the plant when they inputted a company with a similar name into their database. Then read Baxter’s response to this fiasco. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1357 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

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