FDA 483 - WuXi AppTec Inc. - May 02, 2024

During an FDA inspection from April 22 to May 2, 2024, WuXi AppTec Inc., a contract testing laboratory in Marietta, GA, was issued a Form FDA 483 outlining seven significant observations. These findings primarily highlight inadequate controls and procedures affecting aseptic processing and overall laboratory integrity. Key violations included substantial deficiencies in environmental controls. Sporicidal and fogging agents used for disinfection lacked demonstrated efficacy against contaminants, and the firm had not adequately evaluated all critical surfaces or the bioburden testing disinfection process, raising cross-contamination risks. Furthermore, human tissue sub-samples were not properly labeled, increasing the potential for mix-ups, and in-house prepared testing media was released "at risk" without complete growth promotion validation, jeopardizing test reliability. The inspection also identified a failure to take appropriate corrective actions, such as re-sampling or cleaning, when environmental monitoring action levels for microorganisms were exceeded. Critical equipment, including autoclaves, had overdue media qualifications, and humidity levels in controlled environments were neither adequately monitored nor controlled. Lastly, environmental monitoring was incomplete, as floor sampling for microorganisms in gowning areas was not conducted. WuXi AppTec Inc. is required to provide a robust response detailing corrective and preventive actions to address these regulatory deficiencies and ensure compliance with quality system requirements for contract testing laboratories.