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

Source: https://www.keypedia.com/records/warning_letter/lisanby-sarah-h-md/ee29e117-81cd-4612-a7bd-9640b9ef322d

> FDA WARNING_LETTER for Lisanby, Sarah H., M.D. on June 09, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lisanby, Sarah H., M.D.
- Inspection Date: 2008-06-09
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)

Company: https://www.keypedia.com/companies/lisanby-sarah-h-md/1c07b70f-4821-484b-be4e-00c2c6af8d81

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7