# Clinical research and labs warning letters: 36

Updated October 6, 2026.

FDA issued 36 warning letters on clinical research and labs from December 3, 2024 to October 6, 2026, to 36 companies; 0 have a closeout letter. The newest, issued October 6, 2026 by the Center for Drug Evaluation and Research, went to Lovelace Biomedical Research Institute (Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies).

## The full list

FDA warning letters: clinical research and labs: 36 rows for $5, FDA warning letters issued November 12, 2024 to October 30, 2026. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. The new rows each week by email, about 1 row a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, subject group, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-warning-letters/subject/clinical-research

SpecStream is the live web data engine for teams and agents. It reads FDA's warning letters table each morning, and this page is that reading. Ask for the offices, subjects or companies you follow and each new letter arrives in your sheet, CRM, Slack or agent as FDA posts it.

- Letters: 36
- With closeout: 0
- Latest issued: October 6, 2026

## Newest letters

The newest 36 of 36 by issue date, each linked to the letter on fda.gov.

| Issued | Company | Issuing office | Subject | Posted | Source |
| --- | --- | --- | --- | --- | --- |
| October 6, 2026 | Lovelace Biomedical Research Institute | Center for Drug Evaluation and Research | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovelace-biomedical-research-institute-725136-10062026) |
| August 27, 2026 | Stephen J. Fallon, Ph.D. | Center for Biologics Evaluation and Research | Bioresearch Monitoring Program/Institutional Review Board (IRB) | September 8, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stephen-j-fallon-phd-728673-08272026) |
| July 27, 2026 | Maria E. De La Torre Silva, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maria-e-de-la-torre-silva-md-735690-07272026) |
| July 10, 2026 | Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026) |
| May 28, 2026 | Jose M. Carpio, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | June 9, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jose-m-carpio-md-730966-05282026) |
| May 19, 2026 | HealthPartners Neuroscience Center Research and Innovation | Center for Drug Evaluation and Research | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | June 2, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthpartners-neuroscience-center-research-and-innovation-725333-05192026) |
| May 4, 2026 | Naseem A. Jaffrani, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | May 19, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naseem-jaffrani-md-729750-05042026) |
| April 29, 2026 | Sourav K. Mishra, M.D. / All India Institute of Medical Sciences | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | May 19, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sourav-k-mishra-md-all-india-institute-medical-sciences-724881-04292026) |
| April 29, 2026 | Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | May 12, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mukesh-b-chandre-md-mbbsashirwad-hospital-research-centre-724911-04292026) |
| March 27, 2026 | Ehsan Sadri, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | April 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ehsan-sadri-md-726342-03272026) |
| March 12, 2026 | Adnan Dahdul, MD | Office of Compliance and Biologics Quality | Clinical Investigator/BIMO | May 26, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adnan-dahdul-md-719607-03122026) |
| March 9, 2026 | Vedic Lifesciences Pvt. Ltd. | Center for Drug Evaluation and Research | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | March 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vedic-lifesciences-pvt-ltd-722446-03092026) |
| February 2, 2026 | Bertrand P. Cole, D.O. | Center for Drug Evaluation and Research | Clinical Investigator | February 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bertrand-p-cole-do-723495-02022026) |
| February 2, 2026 | Mark S. Dacey, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mark-s-dacey-md-722942-02022026) |
| January 13, 2026 | Center For Immunology Science, LLC | Center for Drug Evaluation and Research | Sponsor/Investigator | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-immunology-science-llc-719933-01132026) |
| January 8, 2026 | Prodrome Sciences USA, LLC | Center for Drug Evaluation and Research | Sponsor/Unapproved Misbranded | January 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prodrome-sciences-usa-llc-717959-01082026) |
| December 22, 2025 | Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purushothaman-damodara-kumaran-md-senthil-specialty-hospital-721325-12222025) |
| December 12, 2025 | Maria A. Carballosa, M.D. | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | December 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maria-carballosa-md-720805-12122025) |
| December 11, 2025 | Palamur Biosciences Private Limited | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/palamur-biosciences-private-limited-708579-12112025) |
| December 11, 2025 | Devalingam Mahalingam, M.D., Ph.D. | Center for Drug Evaluation and Research | Clinical Investigator | December 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/devalingam-mahalingam-md-phd-721145-12112025) |
| November 10, 2025 | Verdure Sciences, Inc. | Center for Drug Evaluation and Research | Sponsor/Investigator | November 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/verdure-sciences-inc-717259-11102025) |
| September 19, 2025 | Pamela K. Den Besten, DDS, MS | Center for Drug Evaluation and Research | Clinical Investigator (Sponsor) | September 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pamela-k-den-besten-dds-ms-715245-09192025) |
| September 17, 2025 | Ralph A. DeFronzo, M.D. | Center for Drug Evaluation and Research | Clinical Investigator/Sponsor | September 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ralph-defronzo-md-716773-09172025) |
| September 4, 2025 | Shirish M. Gadgeel, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | September 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shirish-m-gadgeel-md-716181-09042025) |
| July 11, 2025 | Jiangsu Kerbio Medical Technology Group Co. | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-kerbio-medical-technology-group-co-705188-07112025) |
| June 26, 2025 | Mark J. Savant, M.D | Center for Drug Evaluation and Research | Clinical Investigator | July 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mark-j-savant-md-712306-06262025) |
| June 25, 2025 | CCIC Huatongwei International Inspection Co., Ltd. | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ccic-huatongwei-international-inspection-co-ltd-704332-06252025) |
| June 18, 2025 | Peter Michael, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | July 1, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peter-michael-md-711299-06182025) |
| April 30, 2025 | American Behavioral Research Institute, LLC | Center for Drug Evaluation and Research | Clinical Investigator (Sponsor) | June 10, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-behavioral-research-institute-llc-705629-04302025) |
| April 28, 2025 | Nana Barseghian, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | May 6, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nana-barseghian-md-708009-04282025) |
| March 25, 2025 | Americo F. Padilla, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | March 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/americo-f-padilla-md-700447-03252025) |
| March 24, 2025 | United Health Products, Inc. | Center for Devices and Radiological Health | Bioresearch Monitoring Program/Institutional Review Board (IRB) | May 20, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/united-health-products-inc-697777-03242025) |
| March 5, 2025 | Mehran Michael Bahrami, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | March 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mehran-michael-bahrami-md-703689-03052025) |
| February 4, 2025 | ISOThrive, Inc. | Center for Drug Evaluation and Research | Clinical Investigator | February 11, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isothrive-inc-688547-02042025) |
| December 3, 2024 | Han C. Phan, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | December 3, 2024 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/han-c-phan-md-696989-12032024) |
| December 3, 2024 | Applied Therapeutics, Inc. | Center for Drug Evaluation and Research | Sponsor | December 3, 2024 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/applied-therapeutics-inc-696833-12032024) |

## Subjects as FDA words them

| Subject | Letters | Latest |
| --- | --- | --- |
| Clinical Investigator | 15 | July 27, 2026 |
| Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | 6 | October 6, 2026 |
| In Vivo Bioavailability-Bioequivalence Studies – Clinical | 5 | July 10, 2026 |
| Bioresearch Monitoring Program/Institutional Review Board (IRB) | 2 | August 27, 2026 |
| Sponsor/Investigator | 2 | January 13, 2026 |
| Clinical Investigator (Sponsor) | 2 | September 19, 2025 |
| Clinical Investigator/BIMO | 1 | March 12, 2026 |
| Sponsor/Unapproved Misbranded | 1 | January 8, 2026 |
| Clinical Investigator/Sponsor | 1 | September 17, 2025 |
| Sponsor | 1 | December 3, 2024 |

## By issuing office

| Issuing office | Letters | Latest |
| --- | --- | --- |
| [Center for Drug Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-drug-evaluation-and-research) | 30 | October 6, 2026 |
| [Center for Devices and Radiological Health](https://specstream.ai/data/fda-warning-letters/office/center-for-devices-and-radiological-health) | 4 | December 11, 2025 |
| [Center for Biologics Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-biologics-evaluation-and-research) | 1 | August 27, 2026 |
| Office of Compliance and Biologics Quality | 1 | March 12, 2026 |

## By year issued

| Year | Letters | Latest |
| --- | --- | --- |
| [2025](https://specstream.ai/data/fda-warning-letters/year/2025) | 18 | December 22, 2025 |
| [2026](https://specstream.ai/data/fda-warning-letters/year/2026) | 16 | October 6, 2026 |
| [2024](https://specstream.ai/data/fda-warning-letters/year/2024) | 2 | December 3, 2024 |

## Where FDA publishes its warning letters

- [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).