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FDA Inspection of Frankfurt, Germany Facility
Date: 02/09/2011 (Date of FDA Warning Letter)
Misconduct Type: Health
Enforcement Agency: Health and Human Servs.
Contracting Party: None
Court Type: N/A
Disposition: Investigative Finding
Synopsis: A U.S. Food and Drug Administration (FDA) inspection of Sanofi Aventis Deutschland GmbH’s Frankfurt, Germany facility in September 2010 identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals. The violations included failing to establish or follow appropriate written procedures designed to prevent microbiological contamination of the Apidra insulin treatment; failing to establish separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing; and failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education training, and experience to enable that person to perform the assigned functions.