Concord Biomedical Science and Emerging Technologies, Inc. – FDA EIR, May 23, 2019

Concord Biomedical Science and Emerging Technologies, Inc. (CBSET) underwent a routine Good Laboratory Practice (GLP) inspection from May 15-23, 2019, focusing on nonclinical laboratory studies. The inspection identified two primary observations on a Form FDA 483. First, the company failed to ensure the timely transfer of raw data, documentation, and final reports to archives for several studies completed between December 2018 and March 2019. This lapse concerns the study director's responsibility to assure proper archival at study close. Management explained delays were due to extensive sponsor requests for raw data copies and committed to a new policy to archive all study materials within two weeks of completion. Second, changes detailed in a protocol amendment for a study were implemented before formal approval by the Study Director and were not documented as deviations. CBSET acknowledged this and stated they would ensure future protocol changes are properly approved and any deviations reported. Further discussions included an agreement with an off-site animal housing facility lacking coverage for all performed study activities, unarchived measurement data, an incomplete SOP for animal drinking water quality, and inadequate documentation of instrument cleaning and reagent changes. CBSET plans to submit a written response to the FDA 483.