FDA 483 - Labcorp Bedford LLC. - September 14, 2021

The FDA inspected Toxikon Corporation in Bedford, MA, and found significant issues in their nonclinical laboratory studies. The study director failed to ensure accurate data recording, verification, and proper documentation of experimental data and unforeseen circumstances. Furthermore, the quality assurance unit did not adequately review final study reports, leading to the inclusion of erroneous data and incomplete descriptions of study methods and deviations.