FDA EIR - CAO Group, Inc. - May 07, 2018

This Establishment Inspection Report details a comprehensive FDA for-cause inspection of CAO Group, Inc. from May 1 to May 7, 2018. The inspection focused on the firm's role as a sponsor of a clinical trial for an investigational medical device, guided by Compliance Program 7348.810 (Sponsors, Contract Research Organizations and Monitors) and relevant 21 CFR Part 812 regulations.

The FDA issued an FDA-483 with ten observations, highlighting significant deficiencies in the firm's conduct. Main violations included initiating an investigation without prior FDA and Institutional Review Board (IRB) approval, and the absence of written procedures for monitoring the investigational device study. The company failed to select qualified investigators, provide adequate study information, or ensure proper monitoring. Specifically, an unlicensed individual was allowed to serve as an investigator and received investigational devices. CAO Group Inc. also failed to ensure investigator compliance, terminate participation when non-compliance occurred, or retrieve devices from non-compliant investigators.

Additional issues included the lack of signed investigator agreements and a widespread failure to maintain required study records, such as subject health history, device exposure details, adverse event reporting, calibration, device serial numbers, and service records. Incomplete records of investigational device shipments and a failure to notify FDA of study record transfers were also cited. Management was informed of their responsibility to adhere to regulations and advised of their right to respond to the FDA-483 within fifteen business days.