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...]