FDA EIR - Medicilon/Mpi Prec - September 15, 2017

An FDA inspection of Medicilon Preclinical Research (Shanghai) LLC, a nonclinical laboratory, was conducted from September 11-15, 2017, under Good Laboratory Practice (GLP) regulations. The inspection identified significant issues impacting data quality and integrity, leading to the issuance of a Form FDA 483 with multiple observations. Key violations included inadequate Standard Operating Procedures (SOPs) for critical processes like Ames assay colony counting and necropsy organ re-weighing, which lacked sufficient detail and verification steps. The facility also failed to maintain historical control data for genotoxicity studies, despite reports referencing them. Data recording inaccuracies were prevalent; for instance, "death time" in the electronic system was incorrect, and blood collection times were demonstrably impossible. Equipment management was deficient, with unaddressed "replace HEPA" warnings and undocumented "do not use" statuses. Furthermore, studies remained classified as "ongoing" for extended periods due to sponsor non-response, without a clear protocol for finalization. Management acknowledged the observations and promptly initiated corrective actions. These included drafting new detailed SOPs, compiling historical control data, separating test and control articles, implementing accurate death time recording in their system, and planning synchronized laboratory clocks. The firm provided a written response to the FDA 483 observations, indicating a commitment to address the identified deficiencies.