FDA EIR - WuXi AppTec Inc. - April 11, 2019

An FDA inspection of WuXi Apptec, Inc.'s Marietta, Georgia facility was conducted from April 9 to April 11, 2019. This unannounced, comprehensive inspection was performed under Compliance Program 7341.002, specifically for Human Cells, Tissues, Cellular and Tissue Products, with a focus on preventing the introduction, transmission, and spread of communicable diseases. The inspection evaluated the control laboratory's adherence to current good tissue practice (CGTP) regulations, including facilities, environmental controls, equipment, supplies, processing, and storage related to sterility and bioburden testing of human tissue samples. The regulatory review involved a walkthrough of the laboratories, examination of operational procedures, and a detailed assessment of records covering environmental monitoring, microbial testing, quality assurance, and corrective actions. Direct observations of sample receipt and immersion sterility testing were also part of the process. Significantly, the inspection concluded without any adverse findings. No FDA-483, Inspectional Observation form, was issued, and no items of concern were raised with the laboratory's management. This outcome indicates that WuXi Apptec, Inc. was found to be in compliance with the relevant regulatory framework, and consequently, no corrective actions were required from the FDA. This mirrors the previous inspection in 2016, which also resulted in a "No Action Indicated" classification.