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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
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.