FDA 483 - Pfizer Inc. - October 27, 2010

An FDA inspection of Groton Laboratories, Pfizer Inc. in Groton, CT, a non-clinical laboratory, revealed significant issues with data management and quality assurance. The study director failed to ensure timely archiving of raw data for multiple studies. Additionally, the quality assurance unit failed to adequately review final study reports, leading to discrepancies between reported results and source data.