Warning Letter — Maria E. De La Torre Silva, M.D.
The FDA issued a Warning Letter to Maria E. De La Torre Silva, M.D., following an inspection that identified deficiencies in the conduct of clinical investigations. The source indicates that the Center for Drug Evaluation and Research (CDER) issued the letter on July 27, 2026.
Clinical investigators, site management organizations, and sponsors involved in drug development trials overseen by CDER.
A Warning Letter to a clinical investigator often signals a failure to adhere to the investigational plan or a failure to maintain adequate records. Such deficiencies can undermine the reliability of clinical trial data and raise concerns regarding the protection of human subjects. For sponsors, this may necessitate a re-evaluation of data integrity from the affected site and could potentially impact the validity of a New Drug Application (NDA).
Clinical investigators should perform a comprehensive audit of all trial documentation to ensure strict adherence to protocol-defined inclusion/exclusion criteria. QA teams must verify that all required diagnostic assessments and screenings are documented in the source files before participant enrollment.
FDA Warning Letter issued to: Maria E. De La Torre Silva, M.D.. 07/27/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maria-e-de-la-torre-silva-md-735690-07272026
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