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Federal Contractor Misconduct Database (FCMD)

The federal government routinely awards contracts to companies with histories of misconduct, including contract fraud and other violations. POGO believes that providing this website will help to improve contracting decisions and increase public knowledge of how the government spends billions of taxpayer dollars each year. Read more…

FDA Inspection of Frankfurt, Germany Facility

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.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
N/A
Disposition
Investigative Finding
Date of FDA Warning Letter
2/9/2011
Contractors Involved Penalty
Total
Sanofi-Aventis $0
Further Information Released
FDA Warning Letter 5/21/2011

Federal Contractor Misconduct Database