Issued to HealthPartners Neuroscience Center Research and Innovation. Serious post-market compliance violation.
Issued
May 19, 2026Product
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Company
HealthPartners Neuroscience Center Research and Innovation
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to HealthPartners Neuroscience Center Research and Innovation concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of Data integrity and records, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on May 19, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.