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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 Bridgewater, NJ Facility

A U.S. Food and Drug Administration (FDA) inspection of a Sanofi-Aventis pharmaceutical facility in April and May 2010 found the company failed to comply with the postmarketing reporting requirements of the Federal Food, Drug, and Cosmetic Act. The violations included inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events of products including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill; failure to submit serious and unexpected adverse drug experience (ADE) reports within 15 calendar days to FDA; and failure to include all postmarketing studies in the Annual Report to FDA.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
N/A
Disposition
Investigative Finding
Date of FDA Warning Letter
1/28/2011
Contractors Involved Penalty
Total
Sanofi-Aventis $0
Further Information Released
FDA Warning Letter 5/21/2011

Federal Contractor Misconduct Database