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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