FDA Inspection
Cassandra E. Curtis, M.D.Cassandra E. Curtis, M.D. – FDA Inspection, Sep 14, 2016
Record Details
This FDA Inspection record concerns Cassandra E. Curtis, M.D., with an inspection on September 14, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cassandra E. Curtis, M.D.
- Inspection Date
- September 14, 2016
- Product Type
- Drugs
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ID · 97cc0c19-f7c0-410a-aadf-5f07adb2105e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 986615
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 11Electronic records
- 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
- 21 CFR 312.62(a)Unused drug disposition (investigator)
- 21 CFR 312.64(d)Financial info update
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