FDA Inspection
Stephen Huddleston MDStephen Huddleston MD – FDA Inspection, Oct 11, 2018
Record Details
This FDA Inspection record concerns Stephen Huddleston MD, with an inspection on October 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 66630ff9-759f-43ab-b777-25711e332d44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068402
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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