Health Partners Neuroscience Center Research and Innovation – FDA 483, Mar 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.
- Inspection date
- March 21, 2025
- Product type
- other
ID · 24cc2bc3-2430-4c77-87b4-9ea5c3ab08bc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.