FDA Inspection
Francois Alesch, M.D., Prof.Francois Alesch, M.D., Prof. – FDA Inspection, Jan 13, 2016
Record Details
This FDA Inspection record concerns Francois Alesch, M.D., Prof., with an inspection on January 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Francois Alesch, M.D., Prof.
- Inspection Date
- January 13, 2016
- Product Type
- Devices
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ID · 0edf4ef0-aebd-4942-9585-071b25d455ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 961590
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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