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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 New York City Facility

A U.S. Food and Drug Administration (FDA) inspection of Pfizer’s New York City location conducted from June through August 2009 found violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements with regard to many of its products including Lipitor, Selzentry, Lyrica, Camptosar, and Viagra. Violations included failing to submit Adverse Drug Experience (ADE) reports to FDA within the required time; inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse events; failing to submit adverse drug experiences that are both serious and unexpected to FDA within the required time; and failing to submit a 15-day Alert report for adverse drug experiences obtained from postmarketing studies in which the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience.

Misconduct Type
Health
Enforcement Agency
Health and Human Services
Contracting Party
None
Court Type
N/A
Disposition
Investigative Finding
Date of FDA Warning Letter
5/26/2010
Contractors Involved Penalty
Total
Pfizer, Inc. $0
Further Information Released
FDA Warning Letter 5/21/2011

Federal Contractor Misconduct Database