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CBER Warning Letters - 2004

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The Warning Letters are arranged in order by date, with the most recent letter added to the top of the list. Additional Warning Letters are available from the FDA Freedom of Information Reading Room, Warning Letters.

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Aventis Behring, L.L.C., Promotional Claims/False & Misleading - 10/12/2004 - (PDF), (Text)

Frenette, Gary, M.D., Ph.D, Clinical Investigator - 10/4/2004 - (PDF), (Text)

Richards, Jon M., M.D., Ph.D., Clinical Investigator - 10/4/2004 - (PDF), (Text)

ZLB Bioplasma, Inc, Promotional Claims/False & Misleading - 9/14/2004 - (PDF), (Text)

Sokol, Dawn M., M.D., Clinical Investigator - 9/10/2004 - (PDF), (Text)

Belleza Integral C.A, Unapproved New Drug/Lacks New Drug Application - 8/31/2004 - (PDF), (Text)

www.bellezaintegral.com, Unapproved New Drug/Lacks New Drug Application - 8/31/2004 - (PDF), (Text)

Bilchik, Anton J., M.D., Ph.D, Clinical Investigator - 8/31/2004 - (PDF), (Text)

Aventis Pasteur SA, CGMP - 8/16/2004 - (PDF), (Text)

Novo Nordisk Pharmaceuticals, Inc, Promotional Claims/False & Misleading - 8/9/2004 - (PDF), (Text)

Crystal Laboratory, Inc, Biological Product Establishment Standard/Adulterated - 8/6/2004 - (PDF), (Text)

GlaxoSmithKline Biologics S.A., Promotional Claims/Misbranded - 7/6/2004 - (PDF), (Text)

Everglo-Natural Veterinary Services, Inc, False and Misleading Claims/Misbranded - 6/24/2004 - (PDF), (Text)

OMRIX biopharmaceuticals, Ltd, Promotional Claims/Misbranded - 5/27/2004 - (PDF), (Text)

Baxter Healthcare Corp, Promotional Claims/Misbranded - 5/25/2004 - (PDF), (Text)

Dillman, Robert O., M.D., Clinical Investigator - 5/14/2004 - (PDF), (Text)

Shoemaker, Ritchie C., M.D., Clinical Investigator - 5/13/2004 - (PDF), (Text)

Baxter Healthcare Corp, Promotional Claims/Misbranded - 5/11/2004 - (PDF), (Text)

Biologicalmiracle.com, New Drug - 1/16/2004 - (PDF), (Text)

 

 
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