Noble Life Sciences, Inc – FDA 483, Jul 8, 2022

An FDA inspection of Noble Life Sciences, Inc. in Sykesville, MD, a nonclinical laboratory, from June 27 to July 8, 2022, revealed significant deficiencies. Observations included failures in the quality assurance unit to manage deviations and ensure facility security, the use of uncalibrated equipment for environmental monitoring, and the omission of critical data integrity issues, such as the use of an out-of-tolerance pipette for animal dosing, from final study reports.