FDA Inspection
Debra Carter-MillerDebra Carter-Miller – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns Debra Carter-Miller, with an inspection on June 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Debra Carter-Miller
- Inspection Date
- June 11, 2015
- Product Type
- Drugs
View Company Profile
ID · 24d0c495-50d9-4705-882f-7ef7e2a79d88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929334
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.61Unauthorized recipients (investigator)
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.68FDA access to clinical investigator records
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 312.64(b)Safety reports
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(c)Record retention
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