FDA 483 - Jose C. Pinero, M.D. - October 09, 2025

During an FDA inspection conducted from October 2 to October 9, 2025, Jose C. Pinero, M.D., a clinical investigator in Coral Gables, FL, received a Form FDA 483. This document outlines significant observations indicating a lack of adherence to regulatory requirements for clinical investigations.

The inspection identified two primary issues. First, the investigation was not conducted in accordance with the signed statement of investigator and the investigational plan. Specifically, nine out of 107 reviewed study participants were not randomized within the protocol-specified timeframe after providing consent. Second, the firm failed to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation. This included an inability to provide original and contemporaneous records demonstrating participant consent and randomization within the required timeframe, as well as a lack of documentation for six subjects regarding the absence of symptoms as per protocol requirements.

These observations highlight deficiencies in study conduct and record-keeping, which are critical for ensuring the integrity and reliability of clinical trial data under the Federal Food, Drug, and Cosmetic Act. While the FDA 483 itself is not a final determination of compliance, it requires the firm to address these issues and submit a response outlining corrective actions.