FDA Inspection
Mark L. Jewell, MD Clinical InvestigatorMark L. Jewell, MD Clinical Investigator – FDA Inspection, Sep 26, 2014
Record Details
This FDA Inspection record concerns Mark L. Jewell, MD Clinical Investigator, with an inspection on September 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 26, 2014
- Product Type
- Devices
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ID · 097a99a9-d587-48a6-93b4-fe8df54d7169
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898199
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
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