FDA CITES DAKOTA LABORATORIES FOR FAILURE TO ADEQUATELY VALIDATE ASEPTIC PROCESS Comment Excerpts and comments from specific violations follow. Please obtain the complete Warning Letter from FDA's web site. CGMP Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile … [Read more...]
WARNING LETTER SANOFI AVENTIS DEUTSCHLAND GmbH
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...]
