FDA EIR - National Jewish Health - March 09, 2020

National Jewish Health underwent an FDA Good Laboratory Practice (GLP) surveillance inspection from February 20 to March 9, 2020. Conducted under Compliance Program 7348.808, the inspection assessed the Denver-based nonclinical laboratory's adherence to GLP regulations (21 CFR Part 58) for studies supporting an Investigational New Drug (IND) application. Upon conclusion, a Form FDA 483 was issued, outlining three key observations. Firstly, the study director failed to ensure that unforeseen circumstances affecting study quality and integrity were noted and corrected. Specifically, critical processing requirements from a (b)(4) assay kit insert regarding the timely addition of (b)(4) to the (b)(4) were not consistently followed, and the facility's Standard Operating Procedure (SOP) did not accurately reflect these instructions. Secondly, the testing facility lacked adequate written SOPs for nonclinical laboratory study methods to ensure data quality and integrity. Thirdly, the Quality Assurance Unit (QAU) failed to thoroughly review the final study report to ensure it accurately described methods and SOPs, and that reported results consistently reflected raw data. Management acknowledged the observations and committed to responding to the FDA 483 within 15 business days. Potential regulatory actions, including warning letters or rejection of study data, were discussed.