FDA 483 - Altasciences Preclinical Seattle, LLC - July 18, 2025

An FDA inspection of Altasciences Preclinical Seattle, LLC, a nonclinical laboratory in Everett, WA, revealed two significant observations. The firm failed to ensure personnel clearly understood their functions, leading to discrepancies in tissue documentation during histology processing. Additionally, specimens were not adequately identified with crucial information such as the date of collection, which could lead to errors in data recording and storage.