FDA 483 - Pfizer Inc. - December 13, 2024

An FDA inspection of Pfizer Inc.'s nonclinical laboratory in Groton, CT, revealed two significant observations. The firm failed to conduct nonclinical laboratory studies in accordance with the established protocol, specifically regarding dose administration and animal termination dates. Additionally, the study director did not ensure that all raw data and documentation, including email correspondence, were properly transferred to the archives at the close of a study.