Northern Biomedical Research, Inc. – FDA 483, Mar 29, 2024

Northern Biomedical Research, Inc. in Norton Shores, MI, a nonclinical laboratory, received a Form FDA 483 with two observations. The inspection revealed significant issues with inadequate specimen identification and data recording, resulting in numerous instances of mislabeled or switched samples. Additionally, the firm's final study reports failed to include descriptions of all circumstances that could affect data quality, specifically unrecorded protocol deviations regarding sample processing temperatures.