FDA 483 - Altasciences Preclinical Seattle, LLC - September 13, 2019

Altasciences Preclinical Seattle, LLC, a nonclinical laboratory in Everett, WA, was inspected by the FDA. The inspection revealed that the study director failed to assure that unforeseen circumstances affecting a nonclinical laboratory study were noted and addressed. Specifically, out-of-range test article formulation results were not acknowledged or assessed for their impact on the study.