WARNING LETTER
Stephen J. Fallon, Ph.D. MARCS-CMS 728673 —
- Delivery Method:
- Electronic Email
- Reference #:
- CBER-26-728673
- Product:
- Biologics
- Recipient:
- Stephen J. Fallon, Ph.D.
1401 North East 26th Street
Wilton Manors, FL 33305
United States-
- sfallon@latinosalud.org
- Issuing Office:
- Center for Biologics Evaluation and Research (CBER)
United States
WARNING LETTER
CBER-26-728673
August 27, 2026
Dear Dr. Fallon:
This Warning Letter informs you of objectionable conditions observed during a U.S. Food and Drug Administration (FDA) inspection conducted at your clinical study site between June 2, 2025, and June 13, 2025. The FDA Investigators met with you during the inspection to review your conduct and oversight as a clinical investigator of the clinical study entitled, “A study to evaluate the performance, usability, and result interpretation of INSTI® HIV Self-Test when performed by observed intended users in the US” (Protocol CLS-003).
FDA conducted this inspection under the Bioresearch Monitoring (BIMO) Program, which includes inspections designed to review the conduct of research involving investigational products and to help ensure that the rights, safety, and welfare of human subjects are being protected. At the conclusion of the inspection, a Form FDA 483, Inspectional Observations, was issued and discussed with you.
We reviewed the Establishment Inspection Report (EIR), documents accompanying that report and the Form FDA 483 issued to you. Because you did not provide a response to the list of observations from your inspection, we were unable to evaluate your perspective on the findings, your explanations for the deficiencies, or your commitment to implementing further measures to prevent similar problems in the future, along with a clear timeline to achieve any planned implementation.
Based on our review of the Establishment Inspection Report (EIR), documents accompanying that report, and the Form FDA 483, you violated regulations governing the proper conduct of clinical studies involving investigational products, including regulations
published in Title 21 of the Code of Federal Regulations (CFR), part 812 [21 CFR 812] and 50 [21 CFR 50] (available at Code of Federal Regulations Title 21). The applicable provisions of the CFR are cited for each violation listed below. The violations include but are not limited to the following:
1. You failed to properly obtain and document legally effective informed consent in accordance with the provisions of 21 CFR Part 50.27(a) and 21 CFR 812.100.
You did not ensure that informed consents were signed and dated by the subject or the subject’s legally authorized representative at the time of consent, and you did not ensure a copy of the consent was given to the person signing the informed consent form (ICF).
a. Of the 42 ICFs signed by subjects, 35 showed that the study subjects did not personally record the effective consent date. Rather, your study coordinator documented these dates on the ICFs for these study subjects. Additionally, one study subject's ICF lacked documentation of the date of consent.
b. Your study coordinator (CRC) attested that when study subjects requested a copy of their signed ICF, the CRC instructed the enrolled study subjects to sign a new consent form for their records. Another CRC at your study site stated that he did not give subjects a copy of the signed ICF, nor did he ask if they would like to receive one.
Due to these failures, we cannot verify that proper informed consent was performed from study subjects prior to their enrollment in the study. Additionally, we are not able to assess how many enrolled subjects did not receive a copy of their signed ICF as required by the provisions of the 21 CFR 50.27(a).
During the FDA investigator's discussion of the aforementioned findings with you, you acknowledged the observations and confirmed your understanding of the identified deficiencies. You also stated that you did not believe a formal response to the FDA regarding these objectionable observations cited on FDA Form 483 was necessary. As of the date of this letter, we have not received your response to the observations cited on Form FDA 483 that are listed in Item #1a above.
Additionally, we acknowledge that the following findings were not included in the Form FDA 483 you received.
2. You revised and implemented an informed consent form without obtaining approval imposed by an IRB. [21 CFR 812.110(b)]
You modified the language in the Informed Consent Form (ICF) after it was approved by the IRB in three ways with respect to compensation type, who qualified for compensation and when compensation for participation in the study will be received.1 Subject to exceptions not applicable here, informed consent documents must include all elements described in 21 CFR 50.25. Financial compensation for participating in clinical research should be presented to the IRB at the time of initial review.2 Subject to exceptions not applicable here, 21 CFR 50.27 requires that all elements must be approved by the IRB prior to use for subjects’ consent.
3. You failed to ensure that the investigation was conducted in accordance with the signed agreement with the sponsor and the investigational plan. [21 CFR 812.100 and 812.110(b)].
During the inspection, the FDA investigator noted that you did not ensure Study CLS-003 was conducted according to the signed investigator statement; specifically, you failed to provide adequate oversight and supervision of the study. Examples, include, but are not limited to, the following:
a. Study Protocol CLS-003, Section 7 states that each enrolled subject “is provided with 1 [one] unopened INSTI HIV ST kit. Subject performs INSTI® HIV ST observed and without any intervention from the operator. Subject records their INSTI® HIV ST result on the Subject INSTI® HIV ST Result Form.” On the test result record form, the sponsor specifically instructs the following: “The study participant will complete this form for recording their own INSTI® HIV ST result.” However, the inspection revealed that Subjects Participant INSTI® HIV Self-Test Result Record Form was completed by your study site staff throughout the study. According to your CRCs, they recorded subjects’ interpretation on the Participant INSTI HIV Self-Test Result Record Form, when it was to be completed by the subject, per protocol.
When the FDA investigator inquired as to why the subjects did not complete the record form themselves, neither CRC was able to provide an adequate answer. Both CRCs confirmed they asked the subject what their interpretation of the self-test result was prior to completing the Participant INSTI HIV Self-Test Result Record Form. You failed to recognize this discrepancy throughout the study.
b. Protocol Section 13.1 states a list of investigator responsibilities. You signed bioLytical’s Investigator Agreement, certifying that the clinical study would be conducted according to the signed investigator statement, which required maintaining accurate and adequate study records throughout the study. You failed to conduct the study according to the signed Investigator Agreement in that initials documented in the study site’s Delegation of Authority (DOA) log did not match initials in study documents throughout the study, which made it difficult to determine whether or not the study was conducted by the trained, qualified and delegated personnel who are listed in your DOA Log.
We emphasize that as a clinical investigator, it is your responsibility to ensure that your studies for the FDA-regulated products are conducted in accordance with the investigator agreement and the study protocol, in compliance with the FD&C Act and applicable FDA regulations, to protect the rights, safety, and welfare of subjects, and to ensure the integrity of the study data collected at your study site.
4. You failed to maintain accurate, complete, and current records relating to your participation in Study CLS-003 to 21 CFR 812.140(a)(2) and 812.140(a)(3):
a. Your study site failed to maintain the device shipping records, such as Packing List, Certificate of Analysis, Toxic Substance Control Act Certification, and Export Certificate for Medical Devices from the shipment of the investigational device (INSTI® HIV ST) and comparator device involved in Study CLS-003. The FDA investigator was not able to determine if the study devices were delivered to your clinical study site in good condition for use, the dates of shipment, or the device lot numbers. Although you have maintained IP Accountability Log and IP Dispensing Log for both the INSTI HIV ST and comparator test devices, these records are missing the device lot numbers. Due to these source records lacking the lot number used for each study subject, the FDA investigator was unable to verify and confirm the specific lot numbers of the INSTI® HIV ST and comparator test devices used at your study site and verify that products meet regulatory standards throughout the supply chain.
b. Staff initials recorded on many of the source records pertinent to the study, such as Enrollment Questionnaire, Screen and Enrollment Log, Participant’s INSTI® HIV Self Test Result Record Form and Operator Results Form, do not match the staff initials
entered in your study site’s DOA Log. Therefore, it is unclear that you maintained accurate and complete records of the names of all persons who received, used, or disposed of each device.
c. Your study site used White-out to change the original entry of some of the information collected for Study CLS-003. As such, it was impossible to determine what information was initially recorded for some study subject records, and the FDA investigator was not able to evaluate the author or date of those changes.
This letter is not intended to be an all-inclusive list of deficiencies with your clinical investigation. It is your responsibility to ensure adherence to all requirements in the Federal Food, Drug and Cosmetic Act (FD&C Act) and all applicable regulations. You should address any deficiencies and ensure that any ongoing or future studies comply with FDA regulations.
We further note during the inspection that you expressed your intention not to continue serving as a clinical investigator at Latinos Salud, Inc. to conduct clinical studies of FDA regulated products. Regardless of your decision to discontinue your participation in clinical trials of FDA regulated products, we advise that you provide us with a response to the above mentioned violations.
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 or plan to take to correct the listed violations and prevent similar violations in the future. Include any documentation necessary to show that the matters have been appropriately addressed and mediated. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion.
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. FDA has several references available at Clinical Trials and Human Subject Protection for more information on human subject protection and the conduct of clinical research.
Your response should be sent via email to CBERBIMONotification@fda.hhs.gov and send a copy to OIIBIMODivision2Correspondence@fda.hhs.gov.
If you have any questions regarding this letter, please contact the Division of Inspections and Surveillance, CBER at 240-402-8979.
Sincerely,
/S/
Vincent Amatrudo, JD
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc:
Christine Smith, Division Director
FDA OII BIMO Division 2
OIIBIMODivision2Correspondence@fda.hhs.gov
__________________________
1 It is noted in the EIR that Dr. Fallon stated that he was unaware of the ICF changes, and he did not know who had made the changes.
2 See “Payment and Reimbursement to Research Subjects Guidance for Institutional Review Boards and Clinical Investigators” dated January 2018; 21 CFR 50.20.