FDA EIR - Binh Bui-Nguyen, MD - September 19, 2014

An FDA inspection was conducted at the clinical investigator site of Binh BUI-NGUYEN, MD in Bordeaux, France, from September 17-19, 2014. This for-cause inspection, the second for Dr. Bui-Nguyen, aimed to verify data from two investigational drug studies under an Investigational New Drug (IND) application. The inspection revealed significant deficiencies, primarily involving non-adherence to study protocols and inadequate record-keeping practices. Key violations included missing protocol-required laboratory tests, conducting scheduled patient visits outside specified timeframes, and substantial delays in reporting serious adverse events (SAEs) to the sponsor. For instance, some SAEs were considered "planned surgeries" by the investigator and thus not reported promptly, contradicting regulatory expectations for immediate reporting. Additionally, case histories lacked sufficient documentation, with adverse events not fully captured, severity ratings unsupported by physician notes, and conflicting start/resolution dates for reported events in electronic case report forms. An informed consent issue was also noted for one subject where the main study consent was not signed at screening. The inspection also highlighted inadequate investigator training and monitoring from the sponsor. These findings resulted in the issuance of an FDA Form 483, Inspectional Observations, to Dr. Bui-Nguyen, who subsequently provided a written response. The regulatory framework requires clinical investigators to adhere strictly to study protocols and maintain accurate, complete records to ensure patient safety and data integrity.