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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Voluntary Revocation - Bio-Rad Laboratories

February 22, 2012

Our STN:  BL 102866/5037                                 

 
Bio-Rad Laboratories, Inc.
Attention: Mr. Christopher Bentsen
6565 185th Avenue NE
Redmond, WA 98052-5039
                         
Dear Mr. Bentsen:
 
We have been advised by your letter of April 18, 2011, that Bio-Rad Laboratories, U.S. License 1109, has requested voluntary revocation of the biologics license, to discontinue the manufacturing of Human Immunodeficiency Virus Type 1 (HIV-1/Enzyme Immuno Assay (EIA)/Lysate) (STN 102866).
 
Therefore, under the provisions of Title 21, Code of Federal Regulations, section 601.5(a), your biologics license to manufacture Human Immunodeficiency Virus Type 1 (HIV-1/Enzyme Immuno Assay (EIA)/Lysate) is herby revoked, effective this date.
 
It is recommended that a copy of this letter be available for review at the time of FDA inspections.
 
If you have any questions, please contact the Regulatory Project Manager, Cherie Ward-Peralta, at (301) 827-9170.
 
Sincerely yours,
 
 
 
Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and
 Transfusion Transmitted Diseases
Office of Blood Research and Review  
Center for Biologics
 Evaluation and Research