FDA 483 - National Jewish Health - March 09, 2020

National Jewish Health, a GLP Analytical Laboratory in Denver, was cited with a Form 483 for multiple deficiencies during an inspection. The observations highlight failures in study director oversight, inadequate standard operating procedures for nonclinical laboratory studies, and shortcomings in the quality assurance unit's review of final study reports. Additionally, the facility lacked established SOPs for reagent management within its Complement Laboratory.