FDA 483 - Javier Pascual Lopez - October 24, 2025

The FDA conducted an inspection of Dr. Javier Pascual Lopez's clinical investigation site at Hospital Clinico Univ. Virgen de La Victoria in Malaga, Spain, from October 20 to October 24, 2025. The inspection revealed significant compliance issues, primarily focusing on the failure to adhere to the investigational plan. Specifically, the sponsor was improperly exposed to unblinded treatment arm information for subjects, which was not in accordance with the investigational plan's requirement to keep the sponsor blinded at the patient level.

This violation falls under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically Section 704(b), which mandates that inspections report any conditions that may indicate non-compliance with FDA regulations. The FDA's observations are intended to assist the firm in aligning with the regulatory standards enforced by the agency.

The FDA requires Dr. Lopez to address these compliance issues by implementing corrective actions to ensure adherence to the investigational plan and maintain the integrity of the clinical trial process. The firm is encouraged to discuss objections or corrective actions with FDA representatives and submit relevant information to the FDA for review. Failure to comply with these requirements could result in further regulatory actions.