Warning Letter Record: HealthPartners Neuroscience Center Research and Innovation (2026-05-19) — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Letter issued · posted to fda.gov .
Subject as published: Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
TL;DR
The short version: FDA issued a Warning Letter to HealthPartners Neuroscience Center Research and Innovation on 2026-05-19 citing: Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthpartners-neuroscience-center-research-and-innovation-725333-05192026
Argus analysis
HealthPartners Neuroscience Center Research and Innovation (MARCS-CMS 725333) received an FDA Warning Letter dated May 19, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 2, 2026.
GLP letters cite 21 CFR Part 58, which governs the conduct of nonclinical laboratory studies intended to support a research or marketing permit. Typical findings involve study protocol deviations, incomplete raw data retention, or inadequate quality assurance unit oversight — deficiencies that can affect FDA's ability to rely on the underlying study data.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER HealthPartners Neuroscience Center Research and Innovation MARCS-CMS 725333 — May 19, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-05-02 Product: Drugs Recipient: Recipient Name Leah R. Hanson, Ph.D. Recipient Title Senior Director, Neuroscience Research HealthPartners Neuroscience Center Research and Innovation 295 Phalen Boulevard Saint Paul , MN 55130-2455 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-05-02 Dear Dr. Hanson: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at HealthPartners Neuroscience Center Research and Innovation (HPNC) between March 17 and 21, 2025. The investigators representing FDA reviewed the role of HPNC as the testing facility for the following nonclinical laboratory studies of the investigational drug (b)(4) , performed for sponsor-investigator (b)(4) (formerly performed for (b)(4) ). Protocol (b)(4) : “ (b)(4) ” Protocol (b)(4) : “ (b)(4) ” This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure the quality and integrity of study data, in accordance with Title 21 of the Code of Federal Regulations, part 58 (21 CFR 58), Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your April 11, 2025, written response to the Form FDA 483, and your subsequent correspondence dated June 13, 2025. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written responses dated April 11 and June 13, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in 21 CFR 58 governing the conduct of nonclinical laboratory studies. We wish to emphasize the following: 1. Failure of the testing facility management to assure that tests for mixtures of articles with carriers were conducted by appropriate analytical methods to determine the uniformity of the mixture and the concentration of the test or control article in the mixture, as applicable [21 CFR 58.31(d) and 21 CFR 58.113(a)(1)]. The testing facility management for each nonclinical laboratory study must ensure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. For each test or control article that is mixed with a carrier, tests by appropriate analytical methods must be conducted to determine the uniformity of the mixture and to deter…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- When did FDA issue the warning letter to HealthPartners Neuroscience Center Research and Innovation?
- FDA issued the letter (MARCS-CMS 725333) on 2026-05-19 and posted it publicly on fda.gov on 2026-06-02.
- Is the FDA warning letter to HealthPartners Neuroscience Center Research and Innovation publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthpartners-neuroscience-center-research-and-innovation-725333-05192026.
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Warning Letter Record: HealthPartners Neuroscience Center Research and Innovation (2026-05-19) — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-healthpartners-neuroscience-center-research-and-innovation-2026-05-19-warning-le
"Warning Letter Record: HealthPartners Neuroscience Center Research and Innovation (2026-05-19) — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-healthpartners-neuroscience-center-research-and-innovation-2026-05-19-warning-le.
Argus HQ Research. "Warning Letter Record: HealthPartners Neuroscience Center Research and Innovation (2026-05-19) — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-healthpartners-neuroscience-center-research-and-innovation-2026-05-19-warning-le.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_healthpartners_neuroscience_center_research_and_innovation_2026_05_19_warning_le_2026,
title = {Warning Letter Record: HealthPartners Neuroscience Center Research and Innovation (2026-05-19) — Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-healthpartners-neuroscience-center-research-and-innovation-2026-05-19-warning-le},
note = {Accessed: July 13, 2026}
}