FDA WARNING_LETTER - Lisanby, Sarah H., M.D. - June 09, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection from May 19 to June 9, 2008, at Dr. Sarah H. Lisanby's clinical site. The inspection assessed compliance as a sponsor and investigator for studies utilizing the [(b)(4)] and [(b)(4)] devices. Serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Section 520(g) of the Act were identified.

Key violations include: 1. **Failure to obtain FDA approval for investigational plan changes (21 CFR 812.35(a)(1))**: An unapproved increase in the upper age limit from 35 to 75 years was implemented. 2. **Inadequate monitoring of the investigation (21 CFR 812.40)**: Monitoring procedures were not followed, leading to unaddressed deficiencies at a clinical site, including protocol non-adherence by an investigator and incomplete subject data. 3. **Failure to obtain signed investigator agreements (21 CFR 812.43(c)(1), (c)(5))**: Missing CVs and financial disclosure information for participating investigators. 4. **Failure to conduct investigation per plan and regulations (21 CFR 812.100, 812.110(b))**: Enrollment of subjects not meeting eligibility criteria.