FDA 483 - Robert G Perry - September 05, 2025

The Food and Drug Administration (FDA) conducted an inspection of Robert G. Perry, M.D. at Panax Clinical Research in Miami Lakes, FL, from September 2 to September 5, 2025. The inspection, which focused on a specific clinical protocol, resulted in the issuance of an FDA Form 483, detailing significant observations.

The primary finding was that a clinical investigation was not conducted in accordance with its approved investigational plan. Specifically, it was observed that two out of four enrolled and randomized subjects received an incorrect dose of the investigational product. This error stemmed from using an incorrect weight during the dosage calculation, leading to the administration of an improper volume of the study drug to these participants.

This observation highlights a deviation from the established protocol, which is critical for patient safety and data integrity in clinical trials. While the FDA Form 483 itself is an observation report and not a final determination of compliance, it signals that the firm must review and address these conditions. Robert G. Perry, M.D., is expected to discuss these findings with the FDA, outlining any objections or presenting implemented or planned corrective actions to ensure adherence to regulatory requirements and the investigational plan, as mandated by the Federal Food, Drug, and Cosmetic Act.