FDA Inspection
Sabates, Dr NelsonSabates, Dr Nelson – FDA Inspection, Oct 26, 2010
Record Details
This FDA Inspection record concerns Sabates, Dr Nelson, with an inspection on October 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sabates, Dr Nelson
- Inspection Date
- October 26, 2010
- Product Type
- Drugs
View Company Profile
ID · 23981c0a-050b-4dfe-981e-53710f41a894
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 682440
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 312.62(a)Accountability records
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