Skip to the page

Data / FDA warning letters / Clinical research and labs

Clinical research and labs warning letters: 36

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. The list gains about 1 row a month. The new rows come each week by email, $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. The weekly rows run until you cancel, from the link in each delivery.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-warning-letters/subject/clinical-research, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 6, 2026. Source: FDA warning letters (U.S. Food and Drug Administration).

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 request: Every new FDA warning letter on clinical research and labs, with the company, the office and the letter. $10 of credit on sign-up, no card.

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.

  • 36Letters
  • 0With closeout
  • October 6, 2026Latest issued

Newest letters

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

IssuedCompanyIssuing officeSubjectPostedSource
October 6, 2026Lovelace Biomedical Research InstituteCenter for Drug Evaluation and ResearchGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesOctober 13, 2026fda.gov
August 27, 2026Stephen J. Fallon, Ph.D.Center for Biologics Evaluation and ResearchBioresearch Monitoring Program/Institutional Review Board (IRB)September 8, 2026fda.gov
July 27, 2026Maria E. De La Torre Silva, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorAugust 4, 2026fda.gov
July 10, 2026Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.Center for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalJuly 21, 2026fda.gov
May 28, 2026Jose M. Carpio, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorJune 9, 2026fda.gov
May 19, 2026HealthPartners Neuroscience Center Research and InnovationCenter for Drug Evaluation and ResearchGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesJune 2, 2026fda.gov
May 4, 2026Naseem A. Jaffrani, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorMay 19, 2026fda.gov
April 29, 2026Sourav K. Mishra, M.D. / All India Institute of Medical SciencesCenter for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalMay 19, 2026fda.gov
April 29, 2026Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research CentreCenter for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalMay 12, 2026fda.gov
March 27, 2026Ehsan Sadri, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorApril 7, 2026fda.gov
March 12, 2026Adnan Dahdul, MDOffice of Compliance and Biologics QualityClinical Investigator/BIMOMay 26, 2026fda.gov
March 9, 2026Vedic Lifesciences Pvt. Ltd.Center for Drug Evaluation and ResearchGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesMarch 17, 2026fda.gov
February 2, 2026Bertrand P. Cole, D.O.Center for Drug Evaluation and ResearchClinical InvestigatorFebruary 17, 2026fda.gov
February 2, 2026Mark S. Dacey, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorFebruary 10, 2026fda.gov
January 13, 2026Center For Immunology Science, LLCCenter for Drug Evaluation and ResearchSponsor/InvestigatorJanuary 27, 2026fda.gov
January 8, 2026Prodrome Sciences USA, LLCCenter for Drug Evaluation and ResearchSponsor/Unapproved MisbrandedJanuary 20, 2026fda.gov
December 22, 2025Purushothaman Damodara Kumaran, M.D. / Senthil Specialty HospitalCenter for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalJanuary 13, 2026fda.gov
December 12, 2025Maria A. Carballosa, M.D.Center for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalDecember 23, 2025fda.gov
December 11, 2025Palamur Biosciences Private LimitedCenter for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesDecember 30, 2025fda.gov
December 11, 2025Devalingam Mahalingam, M.D., Ph.D.Center for Drug Evaluation and ResearchClinical InvestigatorDecember 30, 2025fda.gov
November 10, 2025Verdure Sciences, Inc.Center for Drug Evaluation and ResearchSponsor/InvestigatorNovember 18, 2025fda.gov
September 19, 2025Pamela K. Den Besten, DDS, MSCenter for Drug Evaluation and ResearchClinical Investigator (Sponsor)September 30, 2025fda.gov
September 17, 2025Ralph A. DeFronzo, M.D.Center for Drug Evaluation and ResearchClinical Investigator/SponsorSeptember 23, 2025fda.gov
September 4, 2025Shirish M. Gadgeel, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorSeptember 9, 2025fda.gov
July 11, 2025Jiangsu Kerbio Medical Technology Group Co.Center for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesAugust 26, 2025fda.gov
June 26, 2025Mark J. Savant, M.DCenter for Drug Evaluation and ResearchClinical InvestigatorJuly 15, 2025fda.gov
June 25, 2025CCIC Huatongwei International Inspection Co., Ltd.Center for Devices and Radiological HealthGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesAugust 26, 2025fda.gov
June 18, 2025Peter Michael, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorJuly 1, 2025fda.gov
April 30, 2025American Behavioral Research Institute, LLCCenter for Drug Evaluation and ResearchClinical Investigator (Sponsor)June 10, 2025fda.gov
April 28, 2025Nana Barseghian, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorMay 6, 2025fda.gov
March 25, 2025Americo F. Padilla, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorMarch 25, 2025fda.gov
March 24, 2025United Health Products, Inc.Center for Devices and Radiological HealthBioresearch Monitoring Program/Institutional Review Board (IRB)May 20, 2025fda.gov
March 5, 2025Mehran Michael Bahrami, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorMarch 18, 2025fda.gov
February 4, 2025ISOThrive, Inc.Center for Drug Evaluation and ResearchClinical InvestigatorFebruary 11, 2025fda.gov
December 3, 2024Han C. Phan, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorDecember 3, 2024fda.gov
December 3, 2024Applied Therapeutics, Inc.Center for Drug Evaluation and ResearchSponsorDecember 3, 2024fda.gov

Subjects as FDA words them

SubjectLettersLatest
Clinical Investigator15July 27, 2026
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies6October 6, 2026
In Vivo Bioavailability-Bioequivalence Studies – Clinical5July 10, 2026
Bioresearch Monitoring Program/Institutional Review Board (IRB)2August 27, 2026
Sponsor/Investigator2January 13, 2026
Clinical Investigator (Sponsor)2September 19, 2025
Clinical Investigator/BIMO1March 12, 2026
Sponsor/Unapproved Misbranded1January 8, 2026
Clinical Investigator/Sponsor1September 17, 2025
Sponsor1December 3, 2024

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research30October 6, 2026
Center for Devices and Radiological Health4December 11, 2025
Center for Biologics Evaluation and Research1August 27, 2026
Office of Compliance and Biologics Quality1March 12, 2026

By year issued

YearLettersLatest
202518December 22, 2025
202616October 6, 2026
20242December 3, 2024

Where FDA publishes its 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. Spot a wrong value? Write to [email protected] with the link to this page.