FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [Read more...]
610.12 CBER PROPOSED STERILITY TESTS
PART 610.12— CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED COMMENT Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. Comments are due by September 19, 2011. For additional information, please see below for a summary or visit the enclosed web site for the full release … [Read more...]
