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.

Bad News for FDA Continues - Feb 18, 2008

A key House Democrat said last week that the Commissioner of the FDA should resign in the wake of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.

"It's just a total lack of leadership," said Rep. Bart Stupak, D-Mich., chairman of the Subcommittee on Oversight and Investigations. He said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.

How does this affect us?
Expect stricter inspections and longer delays when dealing with FDA.

Details can be found in an AP news account. Read it here:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1353 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.

The Bad News for FDA Continues - Feb 17, 2008

A key House Democrat said last week that the Commissioner of the FDA should resign in the wake of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.

"It's just a total lack of leadership," said Rep. Bart Stupak, D-Mich., chairman of the Subcommittee on Oversight and Investigations. He said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.

How does this affect us?
Expect stricter inspections and longer delays when dealing with FDA.

Details can be found in an AP news account. Read it here:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1353 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.

Red Cross fined ... AGAIN! Feb 11, 2008

FDA has fined the American Red Cross $4.6 million for the distribution of unsuitable blood products, brining penalties against the organization to more than $19 million in recent years.

The Red Cross' troubles with FDA date back over 17 years where they have committed "persistent and serious violations" of blood safety laws. Read a news account of FDA's latest action and the Red Cross' announcement. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Insights

• Should it take over 17 years to become compliant?
• What do you think is the root cause problem?
• Suppose it has anything to do with top management and the culture within the Red Cross?

Surely problems this widespread can't be blamed on "operator error." It's not because some technician made too many mistakes. In our opinion it is inexcusable for an organization that's an American icon to have this miserable track record with complying with our nation's regulations for safe and pure products.

GMP Tip
One of our basic lessons when we teach GMP is that compliance costs less than non-compliance. Here's an example you can use in your GMP training to demonstrate this principle.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1344 clients since 1996

NEW for 2008!
Survival Kit for Regulatory Inspections
www.gmptrainingsystems.com/asp/survival_kit_FDA_inspections.asp

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.com

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

Contaminated Syringes Recalled - Feb 4, 2008

A nationwide recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes was issued by AM2PAT, INC. (doing business as Sierra Pre-Filled Inc). They have been found to be contaminated with Serratia marcescens, which has resulted in patient infections. The recall notice contains this sentence:

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Read the Recall Notice. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Tip
Keeping things clean and reducing the probability of contamination is a fundamental principle of GMP. Use this example in your GMP training sessions. Ask participants in your training to discuss the consequences of this recall. Then discuss how contamination can be prevented in your operation.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1337 clients since 1996

Please forward this post to others in your organization who might benefit.