FDA Inspection
Sarah H. Lisanby, M.D.Sarah H. Lisanby, M.D. – FDA Inspection, Oct 29, 2012
Record Details
This FDA Inspection record concerns Sarah H. Lisanby, M.D., with an inspection on October 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sarah H. Lisanby, M.D.
- Inspection Date
- October 29, 2012
- Product Type
- Devices
View Company Profile
ID · 910b1f7b-e636-400a-8fc3-2e829d013389
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806338
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
- 21 CFR 812.43(c)(1)No curriculum vitae in investigator agreement
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