FDA WARNING_LETTER - Health Partners Neuroscience Center Research and Innovation - March 21, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to HealthPartners Neuroscience Center Research and Innovation (HPNC) following an inspection conducted from March 17 to 21, 2025. The investigation revealed significant non-compliance with Good Laboratory Practice (GLP) regulations under the Federal Food, Drug, and Cosmetic Act (21 CFR Part 58) during nonclinical studies of an investigational drug. Key violations included the failure of facility management to verify the concentration and uniformity of drug mixtures before animal dosing and the failure of the Quality Assurance unit to ensure that final reports accurately reflected raw data. Specifically, reports omitted animal deaths and contained inaccurate clinical observation dates. Additionally, the facility lacked equipment capable of properly analyzing blood samples for the animal species used, resulting in missing data. HPNC also failed to establish essential written procedures for animal care, laboratory testing, and sample handling prior to starting the studies. While HPNC proposed corrective actions, the FDA found them inadequate due to a lack of detail regarding staff training and the fact that some corrective testing occurred only after the studies were finished. HPNC is required to provide a written response within 15 business days detailing specific measures to prevent future violations and ensure data integrity. Failure to address these concerns may result in further regulatory action.