National Jewish Health – FDA EIR, Mar 9, 2020

An FDA inspection was conducted at National Jewish Health from February 20 to March 9, 2020, to assess compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58) for nonclinical laboratory studies supporting an Investigational New Drug (IND) application. This was the facility's first GLP inspection, focusing on adherence to GLP for two specific study protocols involving complement analysis.

The inspection resulted in a Form FDA 483, identifying three main observations. These included the study director's failure to ensure unforeseen circumstances affecting study quality and integrity were documented and corrected, and the testing facility's lack of adequate written standard operating procedures (SOPs) to ensure data quality. Additionally, the Quality Assurance Unit (QAU) failed to verify that final study reports accurately described methods, SOPs, and reflected raw data, partly due to not consistently receiving all protocol amendments.

Further issues discussed with management involved discrepancies between kit inserts and SOPs, and concerns with the qualification of in-house standards and buffer preparation. Data audit findings highlighted problems with data precision, unreadable raw data print-outs, and inconsistent practices for repeating analyses on problematic samples. Regulatory sanctions, including warning letters or data rejection, were explained. Management acknowledged the observations and committed to submitting a response to the FDA 483 within 15 business days, with no voluntary corrections made during the inspection.