About POGO's Federal Contractor Misconduct Database (FCMD)
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 »
FDA Inspection of New York City Facility
Date: 05/26/2010 (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 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.