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

WuXi AppTec Inc. in Marietta, GA, a contract testing laboratory, was cited for significant deficiencies in environmental controls, aseptic processing, and quality management during an FDA inspection. Observations included inadequate cleaning and disinfection efficacy, improper labeling of human tissue sub-samples, and unvalidated in-house reagent production. The firm also failed to address environmental monitoring excursions, control humidity, and maintain equipment qualifications, indicating a systemic lack of control over critical laboratory processes.