FDA Inspection
K. Kristene Gugliuzza, MDK. Kristene Gugliuzza, MD – FDA Inspection, May 16, 2016
Record Details
This FDA Inspection record concerns K. Kristene Gugliuzza, MD, with an inspection on May 16, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- K. Kristene Gugliuzza, MD
- Inspection Date
- May 16, 2016
- Product Type
- Biologics
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ID · 6740bdf7-693f-431d-a2e2-20dd4963a436
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972736
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.64(b)Safety reports
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