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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Meeting Summary Cover Letter - Isoplate Solution

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service

                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448


Our Reference: CRMTS #8012                                              Division of Blood Applications
                         Ref. # BN090067                                          Telephone: (301) 827-3524
B. Braun Medical Inc.
Attention: Rebecca A. Stolarick
901 Marcon Boulevard
Allentown, PA 18109
Dear Ms. Stolarick:
Attached is a copy of the memorandum summarizing your June 30, 2011 Type A meeting with CBER. This memorandum constitutes the official record of the meeting. If your understanding of the outcomes differs from those expressed in this meeting summary, it is your responsibility to bring these discrepancies to CBER’s attention for resolution.
If you have any questions, please contact Iliana Valencia, Regulatory Project Manager, at (301) 827- 6161.
Sincerely yours, 
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
 Management Branch
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research