FDA Inspection
Carol RobertsCarol Roberts – FDA Inspection, Dec 16, 2010
Record Details
This FDA Inspection record concerns Carol Roberts, with an inspection on December 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Carol Roberts
- Inspection Date
- December 16, 2010
- Product Type
- Drugs
View Company Profile
ID · 11865691-5b4b-4096-a1f2-797e3c9aaf64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702758
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
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