FDA Inspection
Marema, Robert T. MDMarema, Robert T. MD – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Marema, Robert T. MD, with an inspection on November 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Marema, Robert T. MD
- Inspection Date
- November 21, 2014
- Product Type
- Devices
View Company Profile
ID · c0071b9c-d436-407e-8bb0-a1be639b22ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904587
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
- 21 CFR 50.25(a)(7)Whom to contact
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