FDA Inspection
Michael D. Leise, M.D., Clinical InvestigatorMichael D. Leise, M.D., Clinical Investigator – FDA Inspection, Aug 27, 2021
Record Details
This FDA Inspection record concerns Michael D. Leise, M.D., Clinical Investigator, with an inspection on August 27, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 27, 2021
- Product Type
- Devices
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ID · af281da1-9aa4-43dd-b6ba-5b809de6bdcd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1150171
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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