FDA Inspection
Domenick T. Zero, Dds,msDomenick T. Zero, Dds,ms – FDA Inspection, May 17, 2010
Record Details
This FDA Inspection record concerns Domenick T. Zero, Dds,ms, with an inspection on May 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Domenick T. Zero, Dds,ms
- Inspection Date
- May 17, 2010
- Product Type
- Devices
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ID · 21b033fa-ab8d-4369-9bcb-4f39f5ab3b33
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662258
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 50.55(f)Documentation of permission by parents or guardian
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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