FDA 483 - WuXi AppTec, Inc. - September 07, 2022

WuXi AppTec, Inc. in Saint Paul, MN, a nonclinical lab, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies in GLP compliance, specimen and reagent labeling, use of expired materials, inadequate animal care SOPs, and issues with environmental monitoring follow-up. These findings indicate a lack of robust quality assurance and operational control in critical laboratory processes.