Teck Mun Soo, M. D., Michigan Spine and Brain Surgeons, Southfield, MI, Feb. 21 (Detroit).

FDA conducted an investigation at Michigan Spine and Brain Surgeons on Oct. 20-21, 24-25, 27, and Nov. 1, 2005, to determine whether Soo's activities and procedures relating to participation in a clinical study complied with applicable federal regulations.

The inspection revealed that Soo had failed to ensure the investigation was conducted in accordance with the signed agreement and applicable FDA regulations.

First, FDA noted that Soo failed to report serious AEs in accordance with the investigational plan--which stated that all serious and unanticipated AEs were to be reported to the sponsor within 48 hours of becoming aware of the event; and, within five days of becoming aware of the event a facsimile or copy of the associated AE CRF must be provided to the sponsor.

For example, one subject experienced the following events: breakage of the investigation device, which required repair during surgery; fever of 102.5 F from Dec. 2-12, 2004; and a hematocrit level of 29.1 on Dec. 5, 2004. These events were not reported to the sponsor until Oct. 20, 2005. Another subject experienced a vascular injury that required repair during a December 2004 surgery; but this AE was not reported to the sponsor until June 3, 2005, and not to the IRB until Oct. 18, 2005.

Furthermore, CRFs regarding patient AEs in March 2005--including, aching back pain and nondescript shooting pain into the bilateral buttocks and sacrum, increased visual analogue scale right leg pain greater than 30 points, and severe right knee pain that worsened with bending--were not reported to sponsor until Oct. 19, 2005.

Soo was further cited for failure to complete diagnostic tests and procedures in accordance with the investigational plan; and for not notifying the reviewing IRB of deviations from the investigational plan in non-emergency situations prior to treating the subjects.

Additionally, Soo failed to properly document informed consent for 10 subjects; and, the agency noted that eight subjects were lost to follow-up for varying reasons.

FDA rejected Soo's Nov. 15, 2005, written response, in which Soo claimed to have not reported the patient AEs because they were "anticipated events from the procedure." AE, BiMo; Doc. 13741W