COMMENT CBER issued to Sanofi Pasteur an eleven page, 32 Observation Form FDA 483 following an audit of their Toronto, Canada facilities. The dates of inspection encompassed the time frame of April 10 - 25, 2012. CBER previously published the Warning Letter regarding this subject which was initially noted within this Blog earlier in the week. The most significant … [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...]
SANOFI AVENTIS DEUTSCHLAND GmbH WARNING LETTER
WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. Comment 21 C.F.R. § 211.113(b) states that "appropriate written procedures, designed to prevent microbiological … [Read more...]
