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These memoranda should be available at the FDA District Offices, if not, a copy can be obtained from CBER, Division of Inspections and Surveillance, Office of Compliance, (301) 594-1194.The preparation of products for which there are no published Additional Standards must be described in the establishment's SOP manual and manufactured in accordance with the methods therein.Determine approximately how many units of whole blood are collected annually, how many are autologous, and how many are directed.Also, determine how many units of whole blood and red blood cells (RBCs) are received from outside sources each year, how many are autologous and how many are directed.If you have any questions or need further assistance, in this matter or any other, please feel free to call 1-800-222-0342 or 1-856-423-6300.
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If changes in the name and address, Medical Director, manufacturing procedures, or products have occurred, they should be reported to DBA in order to update the Form FDA-2830.This guide, which provides the most updated interpretation of certain regulations and guidelines, was prepared by the FDA, Office of Regulatory Affairs and the Center for Biologics Evaluation and Research.
