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The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »

Sanofi-Aventis

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

Amount: $0

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.