FDA 483 - Altasciences Preclinical Seattle, LLC - July 14, 2023

Altasciences Preclinical Seattle, LLC in Everett, WA, was inspected by the FDA from July 10-14, 2023. The inspection revealed a significant issue where the study director failed to ensure all raw data and documentation were properly archived at the close of a GLP study. This indicates a lapse in record-keeping practices for nonclinical laboratory studies.