FDA 483 - Nico de Vries, M.D. - August 09, 2013

An FDA inspection was conducted at Nico de Vries, M.D., a clinical investigator based in Amsterdam, Netherlands, from August 5-9, 2013. The inspection resulted in the issuance of a Form FDA 483, highlighting critical observations regarding the conduct of the STAR clinical study, specifically related to record-keeping and procedural compliance for a device study.

The primary violations centered on three areas. First, records for anticipated adverse device effects were found to be inaccurate and incomplete. Several subjects reported issues like sleep disturbances, physical impacts, and device-related pain (e.g., tongue or teeth pain) that were not properly documented as adverse events in the electronic case report forms, contrary to the approved protocol. Second, subject case history records were incomplete, lacking documentation of the individuals who completed essential worksheets such as "Device Check," "Device Implant," and "System Settings During PSG." This omission hinders accountability and data traceability. Third, informed consent records were inaccurate, as the principal investigator's signature indicated they had orally explained consent to subjects, when in fact sub-investigators performed this task.

These observations indicate a need for Nico de Vries, M.D. to strengthen adherence to clinical trial protocols and regulatory expectations for comprehensive and accurate documentation, which are crucial for ensuring subject safety and data integrity in clinical investigations involving medical devices. The firm is expected to address these findings to demonstrate full compliance.