FDA Inspection
Kristin EllisonKristin Ellison – FDA Inspection, Jun 30, 2009
Record Details
This FDA Inspection record concerns Kristin Ellison, with an inspection on June 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kristin Ellison
- Inspection Date
- June 30, 2009
- Product Type
- Devices
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ID · ebb57d89-f068-42ae-b881-0eb2e8727b0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 600075
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
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