Clinical Investigator: FDA Warning Letter to Maria E. De La Torre Silva, M.D., 2026-07-27
Letter issued · posted to fda.gov .
Subject as published: Clinical Investigator
TL;DR
At a glance: The FDA Center for Drug Evaluation and Research (CDER) issued a warning letter dated July 27, 2026 to clinical investigator Maria E. De La Torre Silva, M.D. (MARCS-CMS 735690) following an inspection conducted June 26–July 15, 2025 at her clinical site in Homestead, Florida. The FDA found that Dr. De La Torre Silva failed to ensure investigational protocols were conducted according to their approved plans, including enrolling a subject simultaneously in two clinical trials where the subject received investigational drug from both studies during overlapping periods, and failed to maintain adequate records of drug disposition, with significant discrepancies between self-reported doses, site accountability records, and EDC records across six enrolled subjects.
Argus analysis
# FDA Warning Letter Analysis: Maria E. De La Torre Silva, M.D.
Dr. Maria E. De La Torre Silva, a clinical investigator based in Homestead, Florida, received a warning letter from the FDA's Center for Drug Evaluation and Research (CDER) on July 27, 2026, following an inspection of her clinical site conducted between June 26 and July 15, 2025. The inspection, part of the FDA's Bioresearch Monitoring Program, identified significant violations in the conduct of clinical drug investigations. Dr. De La Torre Silva acknowledged receipt of the inspection findings on August 4, 2025, but the FDA determined her response was inadequate to address the regulatory concerns.
The violations centered on two primary areas under 21 CFR 312. First, under 21 CFR 312.60, Dr. De La Torre Silva failed to ensure investigations were conducted according to the investigational plan. Specifically, she enrolled a subject simultaneously in two separate clinical trials, contrary to explicit protocol exclusion criteria that prohibited participation in concurrent investigations. Second, under 21 CFR 312.62(a), she failed to maintain adequate drug-accountability records. Six subjects showed significant discrepancies between self-reported doses, site records, and returned study drug quantities. Notably, unopened sealed kits with intact tamper-resistant seals were documented as dispensed, while medication questionnaires indicated nightly doses had been taken—an apparent impossibility flagged by the study sponsor. These sections typically require investigators to maintain meticulous oversight of protocol adherence and investigational drug disposition to protect subject safety and ensure data integrity.
Dr. De La Torre Silva stated in her response that the clinical site would be permanently closed and she would cease all investigative activities. However, the FDA found her corrective action plan insufficient because she did not detail preventive measures against future violations. Compliance officers monitoring similar sites should watch for whether Dr. De La Torre Silva pursues any future clinical research activities, which would likely trigger heightened scrutiny from CDER.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Maria E. De La Torre Silva, M.D. MARCS-CMS 735690 — July 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-07-02 Product: Drugs Recipient: Maria E. De La Torre Silva, M.D. 27327 SW 133rd Court Homestead , FL 33032 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-07-02 Dear Dr. De La Torre Silva: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 26 and July 15, 2025. The investigators representing FDA reviewed your conduct of the following clinical investigations: Protocol (b)(4) , “ (b)(4) ,” of the investigational drug (b)(4) , performed for (b)(4) Protocol (b)(4) , “ (b)(4) ,” of the investigational drug (b)(4) , performed for (b)(4) This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your August 4, 2025, written response to the Form FDA 483. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated August 4, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following: 1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]. As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol (b)(4) required you to ensure that all subjects met all eligibility criteria before enrollment in the study. Specifically, Protocol (b)(4) required you to exclude subjects from the study if they were participating in another investigation (clinical trial) during the study. The protocol also prohibited the use of any other investigational product (IP) for the duration of the study. You failed to adhere to these requirements. Specifically, Subject (b)(6) Visit 1 Screening for Protocol (b)(4) occurred on November 6, 2024, and the subject was randomized on the study on November 13, 2024. The subject was dispensed study drug for Protocol (b)(4) between November 13 and December 16, 2024, and completed the study on January 14, 2025. Ho…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Maria E. De La Torre Silva, M.D. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Maria E. De La Torre Silva, M.D. as of 2026-08-04. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Clinical Investigator: FDA Warning Letter to Maria E. De La Torre Silva, M.D., 2026-07-27. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-maria-e-de-la-torre-silva-m-d-2026-07-27-warning-letter
"Clinical Investigator: FDA Warning Letter to Maria E. De La Torre Silva, M.D., 2026-07-27." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-maria-e-de-la-torre-silva-m-d-2026-07-27-warning-letter.
Argus HQ Research. "Clinical Investigator: FDA Warning Letter to Maria E. De La Torre Silva, M.D., 2026-07-27." Digital Empire Holdings LLC. Accessed August 5, 2026. https://argushq.ai/fda/warning-letter/fda-wl-maria-e-de-la-torre-silva-m-d-2026-07-27-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_maria_e_de_la_torre_silva_m_d_2026_07_27_warning_letter_2026,
title = {Clinical Investigator: FDA Warning Letter to Maria E. De La Torre Silva, M.D., 2026-07-27},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-maria-e-de-la-torre-silva-m-d-2026-07-27-warning-letter},
note = {Accessed: August 5, 2026}
}