FDA Inspection
Deitz, M.D., RobertDeitz, M.D., Robert – FDA Inspection, May 28, 2009
Record Details
This FDA Inspection record concerns Deitz, M.D., Robert, with an inspection on May 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Deitz, M.D., Robert
- Inspection Date
- May 28, 2009
- Product Type
- Drugs
View Company Profile
ID · a72f409f-b071-4a4f-8803-fbcb0d43d913
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 585985
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(c)Record retention
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