FDA Cites Jose M. Carpio, M.D. in 2026-05-28 Warning Letter — Clinical Investigator
Letter issued · posted to fda.gov .
Subject as published: Clinical Investigator
TL;DR
Here's the summary: FDA issued a Warning Letter to Jose M. Carpio, M.D. on 2026-05-28 citing: Clinical Investigator. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jose-m-carpio-md-730966-05282026
Argus analysis
Jose M. Carpio, M.D. (MARCS-CMS 730966) received an FDA Warning Letter dated May 28, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: Clinical Investigator. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 9, 2026.
Clinical Investigator letters cite 21 CFR Part 312 (Investigational New Drug Application) and the FDA's Good Clinical Practice (GCP) framework. Typical findings include failure to follow the investigational plan, inadequate recordkeeping of drug disposition, or failure to obtain proper informed consent — findings FDA can escalate to disqualification proceedings under 21 CFR 312.70 if uncorrected.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
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 Jose M. Carpio, M.D. MARCS-CMS 730966 — May 28, 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-45-05-03 Product: Drugs Recipient: Recipient Name Jose M. Carpio, M.D. Jose M. Carpio, M.D. 14750 NW 77th Court, Suite 207 Miami Lakes , FL 33016-1507 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-05-03 Dear Dr. Carpio: 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 May 1 and May 13, 2025. The investigator 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 investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your June 3, 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 June 3, 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: 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 that subjects were dispensed and administered the investigational product (IP) (b)(4) or the control product (CP) (b)(4) for a treatment duration of five days. Specifically, subjects assigned to Cohort 2 (the outpatient cohort) were to receive IP or CP during each outpatient visit on Days 1, 2, and 4, to ensure sufficient daily IP or CP self-administration between Day 1 and Day 5. You failed to adhere to this requirement. Specifically, Subjects (b)(6) , and (b)(6) , who were assigned to outpatient treatment in Cohort 2, were dispensed IP or CP only on Day 1 (April 4, April 7, and April 11, 2023, respectively). However, IP or CP was not dispensed to these subjects during their outpatient visits on Day 2 or Da…
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 FDA violations was Jose M. Carpio, M.D. cited for?
- The FDA Warning Letter to Jose M. Carpio, M.D. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: Clinical Investigator. Classification: Warning Letter.
- When did FDA issue the warning letter to Jose M. Carpio, M.D.?
- FDA issued the letter (MARCS-CMS 730966) on 2026-05-28 and posted it publicly on fda.gov on 2026-06-09.
- Is the FDA warning letter to Jose M. Carpio, M.D. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jose-m-carpio-md-730966-05282026.
- 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.
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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). FDA Cites Jose M. Carpio, M.D. in 2026-05-28 Warning Letter — Clinical Investigator. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-jose-m-carpio-m-d-2026-05-28-warning-letter
"FDA Cites Jose M. Carpio, M.D. in 2026-05-28 Warning Letter — Clinical Investigator." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-jose-m-carpio-m-d-2026-05-28-warning-letter.
Argus HQ Research. "FDA Cites Jose M. Carpio, M.D. in 2026-05-28 Warning Letter — Clinical Investigator." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-jose-m-carpio-m-d-2026-05-28-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_jose_m_carpio_m_d_2026_05_28_warning_letter_2026,
title = {FDA Cites Jose M. Carpio, M.D. in 2026-05-28 Warning Letter — Clinical Investigator},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-jose-m-carpio-m-d-2026-05-28-warning-letter},
note = {Accessed: July 13, 2026}
}