Warning Letter — Jose M. Carpio, M.D.
The FDA issued a warning letter to Jose M. Carpio, M.D., following an inspection by the Center for Drug Evaluation and Research regarding compliance in clinical investigations.
This affects the specific clinical investigator named, as well as clinical trial sponsors, monitors, and regulatory compliance teams involved in studies conducted by this individual.
The issuance of a warning letter by CDER indicates that the FDA identified significant departures from federal regulations governing clinical trials. This suggests internal failures in data integrity or investigator oversight, which could potentially invalidate study results or impact participant safety. Regulatory teams may need to assess the impact on any datasets originating from this investigator's site.
Clinical investigators and sponsors should review current oversight protocols to ensure all study staff are properly trained and that participant safety monitoring adheres strictly to the approved investigational plan. QA teams should perform targeted audits of site-level documentation to confirm protocol adherence.
FDA Warning Letter issued to: Jose M. Carpio, M.D.. 05/28/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jose-m-carpio-md-730966-05282026
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