FDA 483 - Northern Biomedical Research, Inc. - November 13, 2021

Northern Biomedical Research, Inc. in Norton Shores, MI, a nonclinical laboratory, received four observations during an FDA inspection. The findings include failures in personnel understanding of their roles, inadequate equipment calibration affecting data, and issues with animal care such as inappropriate bedding. Additionally, the facility was cited for improper storage of perishable supplies in an uncontrolled warehouse.