FDA Inspection
Joel D. Cooper, M.D.Joel D. Cooper, M.D. – FDA Inspection, Sep 27, 2017
Record Details
This FDA Inspection record concerns Joel D. Cooper, M.D., with an inspection on September 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Marcelo O. Mangalindan (Issuing Officer)
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ID · 649963dc-b5df-4947-8865-1250dabb4202
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026707
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.66Changes in research
- 21 CFR 812.40Sponsors' general responsibilities
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