FDA 483 - Medicilon Preclinical Research, Inc. - October 25, 2024

During an inspection conducted from October 21-25, 2024, the U.S. Food and Drug Administration issued a Form FDA 483 to Medicilon Preclinical Research, Inc., a nonclinical laboratory located in Shanghai, China. The inspection identified significant observations indicating a lack of control over conditions and practices essential for reliable nonclinical studies.Key violations centered on inadequate facility maintenance, with multiple animal rooms showing severe cracking, peeling paint and epoxy flooring, and corrosion. Additionally, a feed storage room was unclean, and a washroom for clean equipment had dirty light covers with insect carcasses. Standard Operating Procedures (SOPs) were found deficient, specifically lacking details on reagent replacement frequency for tissue processing, microtomy, and slide staining, which could impact data quality.Furthermore, the quality assurance unit failed to ensure proper documentation of deviations from approved protocols or SOPs, including discrepancies in archiving dates, unrecorded equipment corrective actions, unsigned control values for urine analyzers, and unverified out-of-range organ weights. Archival materials were also not indexed for expedient retrieval. Finally, a toxicokinetic report for a study was issued without required signatures and dates. Medicilon Preclinical Research, Inc. is now required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards governing nonclinical laboratory studies.