FDA Inspection
Leonard S Marks, MDLeonard S Marks, MD – FDA Inspection, Nov 15, 2013
Record Details
This FDA Inspection record concerns Leonard S Marks, MD, with an inspection on November 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Leonard S Marks, MD
- Inspection Date
- November 15, 2013
- Product Type
- Devices
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ID · d7e5700e-a43f-4e4f-ad6a-51acf9b6c07a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857814
- 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 812.100Investigator lack of informed consent
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