FDA 483 - Prof. Marek Hus - May 09, 2025

An FDA inspection, conducted from May 5-9, 2025, identified a significant observation at the inspected firm regarding its adherence to an investigational plan. The primary issue cited was the failure to follow the study protocol concerning subject dosing based on body weight measurements.

Specifically, the protocol mandates that if a subject's body weight changes by 10% or more from Cycle 1 Day 1, the dose of the investigational product should be re-calculated based on the actual body weight at the time of dosing. During the inspection, FDA representatives observed that for 4 out of 17 subjects enrolled in the study, this critical dosing adjustment was either not performed, or was implemented incorrectly or with significant delay, despite meeting the predefined body weight change criteria. Examples included subjects whose doses were not adjusted despite a 12% weight change, or where dose adjustments were delayed even after weight recovery.

This observation highlights a deviation from good clinical practice, potentially impacting subject safety and data integrity. The regulatory framework under which this observation is reported is Section 704(b) of the Federal Food, Drug and Cosmetic Act. The firm is expected to address these findings by developing and implementing appropriate corrective actions and preventive actions to ensure compliance with the study protocol and relevant regulations. The report does not specify immediate actions beyond the general expectation for the firm to respond to the FDA with their plan to resolve the identified issues.