Comparative Biosciences, Inc – FDA 483, May 17, 2019

An FDA inspection of Comparative Biosciences, Inc.'s nonclinical laboratory in Sunnyvale, CA, revealed significant deficiencies in the labeling of test and control articles, as well as laboratory reagents. Inspectors observed multiple instances where required information, such as expiration dates and lot numbers, was missing from storage containers. These findings indicate potential non-compliance with Good Laboratory Practice regulations concerning material identification and control.