FDA Intercepting Heparin

Step one, get FDA inspectors into China to inspect Heparin while it is being processed. Step two, inspect Heparin at the border. The FDA has announced that all shipments of the active ingredients which make up the blood thinner sold by Baxter, would be tested at the border for signs of impurity. See the story on this development from Dow Jones at:

Dow Jones Story

In an interesting example of how much more seriously the FDA is now taking the Heparin issue, at http://fda.gov they explain the current process as follows:

COLLECT SAMPLES
FDA samples identified lots of heparin Active Pharmaceutical Ingredient (API) and finished heparin for laboratory testing.

TEST FOR CONTAMINATION
Results from new state-of-the art chemical methods developed by FDA reveal contaminant in heparin API that conventional testing could not detect.

TEST FOR ALLERGIC REACTION
FDA and industry are developing animal testing to determine if human adverse reactions are based on allergic reactions and to determine if there is a link to the contaminant.

CROSS CHECK LOTS
FDA is working to identify lots linked to adverse reactions in humans with any corresponding contaminated lots. "
For a full diagram of this process, go to:

FDA Process

Next: FDA Plans Full-Time Staff in China

For information on the recall, click here:

FDA Information

To contact us, call 800-992-9447.
g@gordonjohnson.com

Gordon Johnson is the Owner of the Johnson Law Office.

©Gordon S. Johnson, Jr. 2008

To contact us
call 800-992-9447

For Our Latest Information on Heparin go to our Blog:

Heparin Glossary

Regulator says hospitals need strict heparin rules

The New England Journal of Medicine: MIT Study

FDA: Heparin Warning

Contaminated Heparin Can Do More than Kill

Heparin Lawsuit: Areas of Inquiry

FDA Press Releases

Scott v. Baxter Lawsuit

Reporting Heparin Problems

Understated Adverse Reactions

Baxter Widens Heparin Recall

FDA Intercepting Heparin

FDA Plans For Full-Time Staff in China

Heparin Purity - China Doesn't Seem to Care

Baxter Didn't Know About Absence of Inspection

German Heparin Also Contaminated

Heparin Contaminant Identified

Heparin Recall Timeline

Food and Drug Administration Globalization Act of 2008

Disclaimer
The materials on this World Wide Web site are provided purely for informational purposes and are not legal advice. These materials are intended, but not promised or guaranteed, to be correct, complete, and current. This web site is advertising but is not intended as legal advice. Therefore, the reader should not consider this information an invitation for an attorney-client relationship. Readers should not act or rely upon any information contained in this World Wide Web site and should always seek the advice of competent counsel.
The owner of this web site is a law firm, the Johnson Law Office of Sheboygan, Wisconsin. Attorney Gordon S. Johnson, Jr. is responsible for the content of this website, and all of the pages linked hereto containing the copyright notice: ©Attorney Gordon Johnson.  The Johnson Law Office is licensed to practice in the States of Wisconsin , Illinois and Michigan. The Johnson Law Office does not wish to represent anyone desiring representation based upon their viewing any portion of this World Wide Web site that fails to comply with all legal and ethical rules in such individual's state.   The Johnson Law Office makes no representation that it can obtain the same results as reported in this web site in other legal matters.
The transmission of an e-mail request for information does not create an attorney-client relationship. If you are a client, remember that e-mail may not be secure. Further, when you send an email to a law firm that you have not retained as your attorney, you are may risk disclosing confidential information. Our law firm may ultimately have a conflict of interest with you and you risk making a disclosure of confidential information to a firm that could represent an adversary or someone whose interest could become adverse to you in some way. For this reason we believe it is a far better practice to call with questions rather than email. 800-992-9447. This is the reason that our websites do not include client intake forms found on so many other lawyer and lawyer referral sites.

WE BELIEVE THAT THE FAR PREFERRED METHOD FOR YOU TO CONTACT US IS BY PHONE AT
1-800-992-9447.

Gordon Johnson is the Owner of the Johnson Law Office.

©Attorney Gordon Johnson, 2008