FDA Inspection
Niederman Alan, MDNiederman Alan, MD – FDA Inspection, Oct 16, 2009
Record Details
This FDA Inspection record concerns Niederman Alan, MD, with an inspection on October 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Niederman Alan, MD
- Inspection Date
- October 16, 2009
- Product Type
- Biologics
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ID · c0fb5864-af53-473e-a5c5-fc488c1952a3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 619928
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 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 312.66Changes in research
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