WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH (con't) 2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example, a) The airflow velocity inside critical areas of the aseptic processing operations of Line … [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...]
USP BACTERIAL ENDOTOXIN TEST
The USP has announced that USP<85> will become effective in April 2011. … [Read more...]
Steris Corporation Warning Letter February 9, 2011
Warning Letter February 9, 2011 Steris Corporation “Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)” Comment Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”. While the FDA has approved this use, they recently issued … [Read more...]
NEW Webinars/Seminars — Barry A. Friedman, PhD
Please follow all upcoming webinars/seminars at www.friedmanconsultingllc.com … [Read more...]
