FDA 483 - Labcorp Early Development Laboratories, Inc. - August 30, 2023

An FDA inspection of Labcorp Early Development Laboratories, Inc. in Madison, WI, revealed significant deficiencies in nonclinical laboratory practices. Observations included failures in periodic analysis and timely notification for animal drinking water contaminants, the inability to retain raw data for a nonclinical study, and the study director's failure to ensure protocol adherence and update changes. These issues indicate a lack of control over critical aspects of nonclinical studies and animal welfare.