FDA 483 - Merck Sharp & Dohme LLC - April 30, 2019

An FDA inspection of Merck Sharp & Dohme Corp.'s nonclinical laboratory in West Point, PA, revealed that not all nonclinical laboratory studies were conducted in accordance with their established protocols. Specifically, a study involving toxicokinetic blood collection was found to have instances where animals were dosed prior to sample collection, contrary to the protocol's requirements. This indicates a deviation from study procedures.