Theodoros Katsivas, M.D. – FDA EIR, May 27, 2025

An unannounced FDA inspection of Theodoros Katsivas, M.D., operating under M3 Wake Research, was conducted from May 19-27, 2025. This high-priority BIMO Review-Based inspection, focusing on a clinical investigator for an In Vivo Bioavailability/Bioequivalence study, was governed by compliance program 7348.003 and regulated under Section 505 of the Federal Food, Drug, and Cosmetic Act. While no formal FDA Form 483 (Inspectional Observations) was issued, several critical findings were discussed with management.

The most significant issue was a discrepancy where the randomization schedule and blinding codes did not match for 27 out of 40 enrolled subjects. This raised concerns that Test and Reference investigational products might have been inadvertently switched or mislabeled, making it impossible to definitively verify if subjects received their intended treatment. Other findings included: a protocol-required FSH test not performed for one subject; documentation errors regarding concomitant medications for another; undocumented protocol deviations for two subjects who engaged in sexual intercourse prior to a pH test, which should have mandated rescheduling; and incomplete medical history documentation for at least two subjects, where self-reported conditions were not adequately evaluated for clinical significance or active status.

The firm acknowledged these discussion items and committed to rectifying them. However, the Agency indicated that these findings could still be considered violations of the FD&C Act, potentially leading to advisory actions, administrative actions, civil money penalties, or prosecution upon further review.