FDA Inspection
Yuri A. Saito Loftus, MD, MPH, Sponsor-InvestigatorYuri A. Saito Loftus, MD, MPH, Sponsor-Investigator – FDA Inspection, Feb 8, 2016
Record Details
This FDA Inspection record concerns Yuri A. Saito Loftus, MD, MPH, Sponsor-Investigator, with an inspection on February 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 8, 2016
- Product Type
- Drugs
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ID · 70e6b2aa-32c8-4d6c-815b-2a30348a4c54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 959081
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(c)Record retention
- 21 CFR 50.20Circumstances of obtaining consent
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