Maria A. Carballosa, M.D.

This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Power MD Clinical Research Institute, Hialeah, Florida, USA, between March 4 and 6, 2025. The investigator representing FDA reviewed your conduct of a clinical investigation (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 March 6, 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 March 6, 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 retain records required to be maintained under 21 CFR 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified [21 CFR 312.62(c)].

As a clinical investigator, you are required to retain records of the disposition of the drug, including dates, quantity, and use by subjects, and to retain adequate and accurate case histories that record all observations and other data pertinent to the investigation for each individual administered the investigational drug or employed as a control in the investigation. You are required to retain these records for a period of two years following the date on which a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified.

You failed to adhere to these requirements. Specifically, for Protocol (b)(4), you failed to retain the following:

Records of the disposition of the study drug, including dates, quantity, and use by subjects

Adequate and accurate case histories, including signed and dated informed consent forms, case report forms, and all supporting data

You were required to retain the study records for Protocol (b)(4) because a supplement to a New Drug Application (NDA) had been filed for the indication under study, and the outcome of the application (that is, whether the application is approved or not approved) has not yet been determined.

In your March 6, 2025, written response to the Form FDA 483, you stated that you are aware of your requirement to maintain study records. You also stated that in 2019, Power MD Clinical Research Institute, which operated out of your private practice, was reorganized; that Protocol (b)(4) had concluded; and that the owner of Power MD Clinical Research Institute (Power MD) relocated, giving you no option to keep the records. In your written response, you also stated that FDA was notified and that FDA granted permission for the owners to take the records. During the inspection, you stated that you did not know where the study records were currently located or if they still existed. Finally, in your written response, you stated that if you are involved in clinical trials again, you will make sure that the records are in a place where you have access to them.

While we acknowledge your statement that FDA was notified of and permitted the transfer of records to Power MD, you did not provide any evidence of such notification or agreement. Additionally, your written response is inadequate because you did not provide details about how you plan to prevent similar violations from occurring in future clinical investigations. Specifically, your response does not provide any information about how you will ensure that study records are retained as required by 21 CFR 312.62(c). Without this information, we are unable to undertake an informed evaluation of your written response.

We emphasize that, as a clinical investigator, it is your responsibility to ensure that study records documenting all observations and other data pertinent to the investigation are retained in compliance with FDA regulations. Your failure to retain study records for Protocol (b)(4) as required by FDA regulations raises concerns about the validity and integrity of the data collected at your site.

This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.

This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.

Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov.

Your written response and any pertinent documentation should be addressed to:

Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993