Registration numbers, essentially central file numbers, are not the same as license numbers.The establishment should have a validated pink copy of Form FDA-2830, Blood Establishment Registration and Product Listing, for the current calendar year or evidence of having submitted same.
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.The Blood Bank Inspection Checklist and Report, and the Instruction Booklet for Blood Bank Inspection Checklist and Report, FDA-2609, are no longer in effect.This could be part of the laboratory standard operating procedure (SOP).Millipore Sigma appreciates your use of our products and looks forward to continued service for your laboratory needs.The investigator should offer no advice or recommendation to the manufacturer regarding the preparation of such products. License number, if applicable (and location number) of facilities.
Questions concerning practices which may be hazardous should be addressed to the Division of Inspections and Surveillance (HFM-650) at (301) 594-1194. This will serve to identify establishments in correspondence, applications and other forms of communications.Determine whether unlicensed products are shipped interstate for sale, barter, or exchange and, if so, thoroughly document such shipments.The requirements of 21 CFR 640, Subpart G apply to plasma exchange if the resulting plasma is sold.Since May 1991, CBER issued a number of memoranda to industry, depicting new recommendations, and modifications to previous guidance, in addition to guidelines on quality assurance and validation of computer systems.Although the agency, at the time of this publication, is in the process of revising the regulations on blood and blood products, it will take some time before such revisions are in effect.If the data on the registration form is not correct, list corrections to be made in comments, and instruct the establishment to submit in writing the updated information to the Division of Blood Applications, (HFM-370), 1401 Rockville Pike, Rockville, MD 20852- 1448.