Issued to Center For Immunology Science, LLC. Serious post-market compliance violation.
Issued
January 13, 2026Product
Sponsor/Investigator
Company
Center For Immunology Science, LLC
Review center
CDERStage
Final Decision
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FDA issued a warning letter to Center For Immunology Science, LLC concerning Sponsor/Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Unapproved products and premarket authorization, Quality systems and CAPA, Labeling, claims, and misbranding. 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 January 13, 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.