Rai, Ansaar T., M.D. – FDA Warning Letter, Jun 29, 2007

This Warning Letter to Ansaar T. Rai, M.D., West Virginia University, details objectionable conditions found during an FDA inspection from June 25-29, 2007, concerning the clinical study of a redacted device. The inspection aimed to ensure compliance with federal regulations, data validity, and human subject protection.

Serious violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Section 520(g) of the Act were identified. Key violations include:

1. **Failure to obtain properly dated informed consent:** The informed consent form for one subject was not dated by the subject or representative at the time of consent, despite a co-investigator's signature. A separate HIPAA authorization was deemed insufficient. 2. **Failure to report unanticipated adverse device effects (UADEs):** UADEs for two subjects, including a small redacted and a urinary tract infection for one, and respiratory failure and death for another, were not reported to the sponsor or IRB within the required 10 working days. 3. **Failure to ensure device control and follow the investigational plan:** Investigational devices were stored insecurely with general inventory. Device log sheets lacked patient numbers for specific device components used. The protocol's required pre-treatment, post-procedure, and follow-up evaluations (e.g., liver enzymes, INR