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

WuXi AppTec, Inc., a nonclinical laboratory in Saint Paul, MN, was inspected by the FDA from August 15 to September 7, 2022, resulting in seven observations on a Form FDA 483. The inspection highlighted significant deviations from Good Laboratory Practice (GLP) regulations.

Key issues included the company's failure to consistently inform consulting laboratories and subcontractors about GLP compliance requirements for studies. Critical deficiencies were also noted in specimen management, with incomplete labeling of retained specimens lacking essential identification, study, and collection date information, which could compromise data accuracy. Additionally, the facility was found utilizing expired reagents and solutions, directly affecting the reliability of laboratory results.

Procedural gaps encompassed a lack of established Standard Operating Procedures for crucial animal care activities, such as animal room preparation, movement, and the handling of test and control articles. Inadequate periodic analysis of animal feed and water for contaminants, along with discrepancies in follow-up reporting, raised further concerns. Finally, inconsistent labeling practices were observed for test article storage containers and general laboratory reagents, with missing expiration dates and required release labels. WuXi AppTec is expected to implement comprehensive corrective actions to address these observations and ensure full compliance with regulatory standards.