FDA WARNING_LETTER - Maria E. De La Torre Silva, MD - July 15, 2025

The FDA issued a Warning Letter to Maria E. De La Torre Silva, M.D., following an inspection of her Homestead, Florida, clinical site from June 26 to July 15, 2025. The investigation revealed significant failures to comply with the Federal Food, Drug, and Cosmetic Act and federal regulations (21 CFR Part 312) intended to protect research participants and ensure data reliability. Two primary violations were cited. First, the investigator failed to follow the study protocol by enrolling a subject who was simultaneously participating in another clinical trial, which was specifically prohibited. Second, the site failed to maintain accurate drug accountability records. FDA investigators identified major discrepancies between self-reported dosing and the physical condition of returned medication; notably, several kits were returned with tamper-resistant seals intact despite documentation claiming the medication had been used. In her initial response, Dr. De La Torre Silva noted that the site is now closed and she does not intend to conduct future research. However, the FDA deemed this response inadequate as it lacked specific details on how these violations would be prevented in the future. Dr. De La Torre Silva is required to submit a written response within 15 business days detailing corrective actions and procedures to ensure compliance with FDA regulations, should she ever resume clinical investigations.