FDA 483 - Laboratorio de Control ARJ, S.A. de C.V. - November 20, 2025

An FDA inspection of Laboratorio de Control ARJ, S.A. de C.V., a contract testing facility in Ciudad de México, revealed significant deficiencies in laboratory controls and data integrity. Observations included a lack of concurrent documentation for microbiology data, inadequate quality oversight for environmental monitoring, and failures in aseptic technique during sterility testing. Additionally, equipment used for sterility testing was found to be poorly maintained, indicating a systemic breakdown in quality assurance practices.