Bioresearch Monitoring Filing Memo, July 13, 2010 - Isoplate Solution
MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
DATE: July 13, 2010
FROM: Anthony Hawkins, Bioresearch Monitoring, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
Telephone: 301-827-6338 Fax: 301-827-6748
SUBJECT: Bioresearch Monitoring Filing Memo
Sponsor: B. Braun Medical Inc.
TO: Jan Simak HFM-335
Iliana Valencia HFM-370
Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.
Consumer Safety Officer