FDA Inspection
Emanuel Calenoff, M.D.Emanuel Calenoff, M.D. – FDA Inspection, May 22, 2014
Record Details
This FDA Inspection record concerns Emanuel Calenoff, M.D., with an inspection on May 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Emanuel Calenoff, M.D.
- Inspection Date
- May 22, 2014
- Product Type
- Drugs
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ID · 9393e5ad-7933-43bc-a66c-dbb271e9ae4e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 880280
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.58(a)FDA access to sponsor records
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 312.20(a)Failure to submit an IND
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