FDA 483 - Hagen F. Kennecke, M.D. - May 02, 2024

During an inspection conducted from April 23 to May 2, 2024, the FDA issued a Form 483 to Dr. Hagen F. Kennecke, a clinical investigator, identifying significant deviations from regulatory requirements and study protocol during an investigational new drug (IND) study. The primary issues centered on patient safety and documentation. Dr. Kennecke failed to conduct the investigation in accordance with the signed statement of investigator and investigational plan. Specifically, for the sole enrolled subject, there was a failure to appropriately manage ocular toxicity. Despite protocol requirements to interrupt study drug dosing and refer the subject to an ophthalmologist upon observing ocular toxicity, the subject continued to receive the study drug. Furthermore, a significant delay of over four months occurred before the subject was evaluated by an ophthalmologist, and an ophthalmologic adverse event was not reported to the study sponsor as mandated by the protocol. Additionally, the inspection revealed inadequate maintenance of case histories related to informed consent, as the subject's main consent form was not properly signed and dated before study drug administration. The participant received the investigational drug for over four months before a complete and properly signed informed consent form was obtained. These observations highlight the need for Dr. Kennecke to implement robust corrective actions to ensure compliance with clinical research regulations, investigator responsibilities, and the protection of human subjects.