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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 Bridgewater, NJ Facility

Date: 01/28/2011 (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 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.