Navigation Links
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant
Date:2/18/2008

Agency error means facility linked to fatal lots of injected heparin was ignored, officials say

MONDAY, Feb. 18 (HealthDay News) -- Due to a name mix-up, the U.S. Food and Drug Administration (FDA) failed to inspect a Chinese plant that made the active ingredient in vials of heparin now linked to four U.S. deaths, the agency said in a Monday press conference.

The vials of multi-dose injectable heparin -- suspended from the market earlier this month by the manufacturer, Baxter Healthcare Corp. -- may have caused severe allergic reactions in American patients, four of which proved fatal.

Generally, the FDA inspects all foreign plants that make pharmaceuticals imported into the United States.

However, "when this site was named in the application [by Baxter], the firm selected and sent to the office of compliance for evaluation was not the correct firm. It was another firm with a similar name. We therefore evaluated the firm, with a similar name. Therefore, this particular firm was not put forward for evaluation," said Joseph Famulare, deputy director of FDA's Office of Compliance.

"We have discovered that; we are acting on that by doing our immediate inspection," Famulare said. "Today, this is isolated situation, but the wrong firm was put in to the database. Therefore, this one was not evaluated or scheduled for inspection," he said.

The agency is continuing its investigation into the source of the error, officials said.

A spokesman for China's State Food and Drug Administration told The New York Times on Friday that the FDA-inspected plant was not a drug manufacturer but "a producer of chemical ingredients" and not licensed to make pharmaceutical products.

Michael Rogers, director of FDA's Division of Field Investigations in the Office of Regulatory Affairs, is spearheading the investigation. He told reporters that the agency is uncertain as to what is causing the adverse events linked to use of the injected heparin.

The FDA has an ongoing inspection at Baxter's plant in Cherry Hill, N.J., and at Baxter's supplier, Scientific Protein Labs in Waunakee, Wisc, Rogers said during Monday's teleconference. Starting this week, the FDA also begins investigating the correct plant in China, which makes the active pharmaceutical ingredient in heparin, he said.

"The inspection team will be conducting good manufacturing practicing inspection at the Chinese facility," Rogers said. "The inspection is designed to determine if the Chinese firm is in compliance with FDA regulations. We'll also be focusing on the firm's manufacturing process and how it adheres to the drug applications," he said.

Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA.

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.

It's not clear how long Baxter's production of injectable heparin will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.

More information

For more on heparin, visit the U.S. National Library of Medicine.



SOURCES: Feb. 18, 2008, teleconference with: Michael Rogers, director, Division of Field Investigations, Office of Regulatory Affairs; Joseph Famulare, deputy director, Office of Compliance, U.S. Food and Drug Administration; The New York Times


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. High and mighty: first common height gene identified by researchers behind obesity gene finding
2. Lung Cancer Alliance Stands Behind CT Screening for Lung Cancer
3. The science behind the food we eat and the earth on which it grows
4. Plastic Surgery 2007: Where Truth Behind Emerging Cosmetic Treatments Meets Amazing Reconstructive Advances
5. Second pathway behind HIV-associated immune system dysfunction identified
6. Nationally Recognized Corporations and Retailers Rally Behind breastcancer.org
7. P&G Reports EPS of $0.92, Up 16% Behind 8% Sales Growth
8. Researchers chart the genetic mechanisms behind the genesis of fat cells
9. NCPA President Steve Girouxs Testimony at FDA Behind the Counter Hearing
10. Theres More Than Turkey Behind Holiday Yawns
11. Researchers led by Penn vet uncover the delicate protein balance behind the immune system response
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant 
(Date:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... 23, 2016  Experian Health, the healthcare ... the patient payment and care experience, today ... products and services that will enhance the ... offerings. These award-winning solutions will enable healthcare ... compliant in an ever-changing environment and redefine ...
Breaking Medicine Technology: