Issued to Jose M. Carpio, M.D.. Serious post-market compliance violation.
Issued
May 28, 2026Product
Clinical Investigator
Company
Jose M. Carpio, M.D.
Review center
CDERStage
Final Decision
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FDA issued a warning letter to Jose M. Carpio, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records. 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 May 28, 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.