# FDA WARNING_LETTER - D'Ambrosia, Robert D. M.D. - December 06, 2007

Source: https://www.keypedia.com/records/warning_letter/dambrosia-robert-d-md/df6f5e99-3813-4664-9770-a5f4488e9c84

> FDA WARNING_LETTER for D'Ambrosia, Robert D. M.D. on December 06, 2007. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: D'Ambrosia, Robert D. M.D.
- Inspection Date: 2007-12-06
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: This FDA Warning Letter, dated April 4, 2008, addresses Dr. Robert D. D'Ambrosia regarding objectionable conditions observed during an FDA inspection from November 15 to December 6, 2007. The inspection assessed compliance with federal regulations for a clinical study involving a device.

Serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) were identified. Key violations include:

1.  **Failure to ensure investigational devices were used under supervision and according to the plan (21 CFR 812.100, 812.110(c)):** Dr. D'Ambrosia, as the Principal Investigator, failed to supervise sub-investigators, lacking documentation of oversight, training, or informing them of their obligations. His response was inadequate, lacking a plan for oversight.

2.  **Failure to obtain proper informed consent (21 CFR 50.20, 50.27(a), 812.100, 812.140(a)(3)(i)):** Investigational devices were used without informed consent for multiple subjects. Non-IRB approved or expired consent documents were used, and study procedures were performed before obtaining consent. A misleading statement about device marketing clearance was included in subject update letters. The

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)
- [Doreen M. Kezer](https://www.keypedia.com/people/doreen-m-kezer/44a1c208-466b-4937-adb1-077e5983ba29)

Company: https://www.keypedia.com/companies/dambrosia-robert-d-md/424bb3cc-e94c-48c4-82db-a1dd505cfbbf

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