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.