Sanofi Aventis Deutschland GmbH – FDA Warning Letter, Sep 16, 2010

This FDA Warning Letter, issued to Sanofi Aventis Deutschland GmbH on February 9, 2011, details significant Current Good Manufacturing Practice (CGMP) violations observed during a September 6-16, 2010 inspection of their Frankfurt, Germany facility. These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. Failure to establish or follow appropriate written procedures to prevent microbiological contamination of sterile drug products (21 C.F.R. § 211.113(b)). For example, the firm failed to identify organisms from a sterility test for Apidra lot #OF100 in June 2010, a recurring issue since December 2008. 2. Failure to establish separate or defined areas or control systems to prevent contamination or mix-ups during aseptic processing (21 C.F.R. § 211.42(c)). This includes unacceptable airflow velocity in critical aseptic processing areas of Line (b)(4) and an inadequate environmental monitoring program (e.g., unacceptable glove sampling practices, lack of SOP instructions for sample location/duration). 3. Failure to ensure personnel engaged in drug product manufacture have adequate education, training, and experience (21 C.F.R. § 211.2