FDA 483 - Health Partners Neuroscience Center Research and Innovation - March 21, 2025

Health Partners Neuroscience Center Research and Innovation, a nonclinical laboratory in Saint Paul, MN, was cited for multiple deficiencies during an FDA inspection. Observations included failures in testing article uniformity, quality assurance review of study reports, specimen retention, establishment of standard operating procedures, proper report amendment procedures, and animal water analysis. These issues indicate significant concerns regarding data integrity and adherence to good laboratory practices in nonclinical studies.