StageBio – FDA EIR, Sep 3, 2021

An FDA inspection of StageBio (formerly Tox Pathology Specialist, LLC), a non-clinical laboratory in Frederick, MD, was conducted from August 25 to September 3, 2021. This high-priority surveillance inspection, performed under the Good Laboratory Practice (GLP) regulatory framework (Compliance Program 7348.008) by CDER's Office of Study Integrity and Surveillance, identified two primary objectionable conditions, resulting in the issuance of an FDA-483 form. The first violation involved the use of deteriorated or outdated reagents and solutions, specifically an expired reagent utilized in studies, necessitating re-performance, and another expired reagent found available for use. This contravened 21 CFR 58.83. The second observation highlighted the absence of adequate written standard operating procedures (SOPs) to ensure data quality and integrity (21 CFR 58.81(a)). This included a lack of procedures for documenting and tracking the removal of study materials from temporary storage, as well as insufficient access control measures for the Receiving Room/Temporary Storage Area. StageBio management acknowledged these findings. Corrective actions pledged include revising the SOP for reagent management, implementing refresher training for laboratory personnel, installing a lockable cage in the temporary storage area, and developing an internal tracking request form for material movement. StageBio is required to provide a written response to the FDA-483 observations within 15 business days.