Miami Dade Medical Research Institute

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Miami Dade Medical Research Institute (MDMRI) wishes to address a recent publication by Conexiant News, released in January 2025 and titled “FDA Warning Letter Summary.” The article incorrectly associates our institute with regulatory violations outlined in an FDA warning letter issued to Dr. Americo F. Padilla.

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Other false information regarding FDA warning letters regarding clinical trials that were NOT performed at Miami Dade Medical Research Institure were also published by the following organizations/individuals:

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• Conexiant – January 2025 post by Kerri Miller and Amy Pfeiffer
  The article titled “COVID Research: FDA Issues Warning Letter for Clinical Trial Violations” falsely claims that Dr. Americo F. Padilla was the principal investigator for a pediatric COVID-19 clinical trial conducted at Miami Dade Medical Research Institute (MDMRI). This is entirely untrue. MDMRI specializes in adult clinical trials. Additionally, the post includes a hyperlink to a non-existent FDA webpage, further casting doubt on its reliability.

• Thompson FDA / CBIS – January 31, 2025 post by J.W. Schomisch
  In the article “FDA Sends Investigator Warning Letter Over Informed Consent”, published on the CBIS website, the same false claim is repeated—that Dr. Padilla conducted a pediatric COVID-19 trial at MDMRI. This is false. MDMRI specializes in adult clinical trials. Moreover, the article uses this misleading claim as a gated content hook, requiring users to create an account to access the full post, effectively turning misinformation into a lead-generation tactic.

• Regulatory Focus (RAPS) – January 31, 2025 post by Joanne S. Eglovitch
  The article titled “FDA’s Recent Warning Letters Target BIMO Violations, Unapproved Products” also misstates that Dr. Padilla was involved in a pediatric clinical trial at MDMRI. This claim is false. MDMRI specializes in adult clinical trials. The article further damages credibility by linking to a non-functional FDA webpage.

• Matt Jones / Digital Quality Associates – LinkedIn post dated January 17, 2025
  In a LinkedIn post titled “Important FDA Enforcement Update”, Matt Jones falsely alleges that Dr. Padilla led a pediatric trial at MDMRI. This is incorrect. MDMRI specializes in adult clinical trials The post also includes a link to a non-existent FDA page, contributing to the spread of misinformation.​

• Conexiant post dated January, 2025, edited by Kerri Miller and Amy Pfeiffer, titled: COVID Research: FDA Issues Warning Letter for Clinical Trial Violations".
  In this post Conexiant falsely claimed that Dr. Americo F. Padilla was the principal investigator for a pediatric covid-19 clincal trial that supposedly was conducted Miami Dade Medical Research Institute (MDMRI), but this statement is completely false. MDMRI specializes in adult clinical trials. Furthermore, they have included a link on their post leading to a non-existing FDA website URL.

• Thompson FDA, a division of CBIS also published on the News page of their website on January 31, 2025, an article by J.W. Schomisch titled: "FDA Sends Investigator Warning Letter Over Informed Consent". This post also, falsely claimed that Dr. Americo F. Padilla was the principal investigator for a pediatric covid-19 clincal trial that supposedly was conducted Miami Dade Medical Research Institute (MDMRI), but this statement is completely false. MDMRI specializes in adult clinical trials Furthermore, this article's general information is posted with a link to read more about this false claim that to read the post they require to create an account on their company page, therefore using the article as a lead generating hook for their site.

• Regulatory Focus (RF), an organization by Regulatory Affairs Professionals Society (RAPS), 5635 Fishers Lane, Suite 400, Rockville, Maryland 20852 also published an article on January 31, 2025 posted by Joanne S. Eglovitch, an article titled: "FDA’s recent warning letters target BIMO violations, unapproved products". This post also, falsely claimed that Dr. Americo F. Padilla was the principal investigator for a pediatric clinical trial that supposedly was conducted Miami Dade Medical Research Institute (MDMRI), but this statement is completely false. As a matter a fact, MDMRI specializes in adult clinical trials. Furthermore, they have included a link on their post leading to a non-existing FDA website URL.

• Matt Jones, of Princes Risborough, England, United Kingdom posted on LinkedIn, an article on January 17, 2025 an article titled: " Important FDA Enforcement Update:" This post also, falsely claimed that Dr. Americo F. Padilla was the principal investigator for a pediatric clinical trial that supposedly was conducted Miami Dade Medical Research Institute (MDMRI), but this statement is completely false. MDMRI specializes in adult clinical trials. Furthermore, they have included a link on their post leading to a non-existing FDA website URL. 

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​We would like to clarify, in the strongest and most unequivocal terms, that MDMRI was not involved in the cited violations and was not the subject of the FDA’s warning letter. The regulatory matters referenced in the article are solely related to Dr. Padilla’s independent activities and were not conducted under the oversight, management, or auspices of MDMRI.

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Dr. Padilla has at times served as an external investigator affiliated with specific research studies hosted at our facility. However, the violations described in the FDA’s communication pertain to activities outside of his work with MDMRI and do not reflect our standards, procedures, or institutional conduct.

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Miami Dade Medical Research Institute remains fully compliant with all applicable federal regulations and ethical guidelines governing clinical research. We are committed to transparency, integrity, and the highest level of professional accountability.

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For additional information or clarification, please contact Dr. Onelia Fajardo-Garcia directly at (305) 722-7207 or via email ofajardo@miamedresearch.com