FDA Inspection
Loriaux, Marc M., MD, PhDLoriaux, Marc M., MD, PhD – FDA Inspection, Mar 4, 2015
Record Details
This FDA Inspection record concerns Loriaux, Marc M., MD, PhD, with an inspection on March 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Loriaux, Marc M., MD, PhD
- Inspection Date
- March 4, 2015
- Product Type
- Devices
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ID · ce272b03-d340-4e79-abb0-dfa305fd5e48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 914420
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 50.27(b)(2)Short form: Oral presentation/signing
- 21 CFR 50.27(b)(2)Short form: Summary copy not signed/given
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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