FDA EIR - Dr. Gretel Trullenque, DO - May 24, 2024

The FDA conducted a preannounced, comprehensive inspection of Dr. Gretel Trullenque, DO, and Floridian Research Institute, LLC, in Miami, Florida, from May 14 to May 24, 2024. This clinical investigator inspection, requested by the Center for Drug Evaluation and Research, followed Compliance Program 7348.811, Bioresearch Monitoring, and aimed to assess compliance with the Federal Food, Drug, and Cosmetic Act across two drug protocols.

The inspection identified significant issues, resulting in a Form FDA 483, Inspectional Observations, being issued. For one protocol, four of twelve randomized subjects, who received investigational product and completed the study, did not meet all eligibility criteria at randomization. This included subjects not taking required medications or having exclusionary laboratory values, with some lab results signed off after randomization. For a second protocol, one of thirteen randomized subjects received investigational product despite meeting an exclusion criterion at screening due to a laboratory result.

Additional observations highlighted during discussions included instances where nine subjects had eligibility-affecting data changes post-randomization, and incomplete laboratory collections for ten subjects at Visit 1 for one study. Other findings encompassed a screen-fail subject not entered into the Electronic Data Capture (EDC) system, lack of rater signatures for scale administrations, failure to maintain study-related envelopes, use of an outdated Informed Consent Form (ICF) version, simultaneous completion of scales with conflicting times, and documentation of scale completion by non-delegated personnel. The site also showed inconsistent adherence to proper source documentation principles. An investigational product temperature excursion was not reported to the sponsor, and the affected product was subsequently used.

Dr. Trullenque was informed that these observed conditions could be determined as violations, with potential administrative actions, injunctions, fines, and prosecution available to the FDA.