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

Source: https://www.keypedia.com/records/483/health-partners-neuroscience-center-research-and-innovation/24cc2bc3-2430-4c77-87b4-9ea5c3ab08bc

> FDA 483 for Health Partners Neuroscience Center Research and Innovation on March 21, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Partners Neuroscience Center Research and Innovation
- Inspection Date: 2025-03-21
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-03-21](https://www.keypedia.com/records/warning_letter/health-partners-neuroscience-center-research-and-innovation/d9502018-1a4d-48e6-b872-22df2d33f5bb)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [issuing_officer](https://www.keypedia.com/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [Hugh M. Mcclure](https://www.keypedia.com/people/hugh-m-mcclure/e69b7562-8fb5-4b7d-a506-a9bc0f0e9e43)

Company: https://www.keypedia.com/companies/health-partners-neuroscience-center-research-and-innovation/0755293b-0c29-4d51-9f94-8ac60002e6b8

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d