Issued to Stephen J. Fallon, Ph.D.. Serious post-market compliance violation.
Issued
August 27, 2026Product
Bioresearch Monitoring Program/Institutional Review Board (IRB)
Company
Stephen J. Fallon, Ph.D.
Review center
CBERStage
Final Decision
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FDA issued a warning letter to Stephen J. Fallon, Ph.D. concerning Bioresearch Monitoring Program/Institutional Review Board (IRB). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on August 27, 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.