FDA Inspection
James W. Baker, MDJames W. Baker, MD – FDA Inspection, Jun 19, 2017
Record Details
This FDA Inspection record concerns James W. Baker, MD, with an inspection on June 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d877ce30-19d3-4d69-ba6f-d774a8bd328e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1015871
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 50.55(f)Documentation of permission by parents or guardian
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Other FDA inspections of James W. Baker, MD
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2019 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| May 26, 2016 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| September 19, 2013 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| June 15, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 14, 2009 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for James W. Baker, MD
- FDA Inspection 1096142 - 2019-06-17
- FDA Inspection 991201 - 2016-05-26
- FDA Inspection 850039 - 2013-09-19
- FDA Inspection 673849 - 2010-06-15
- FDA Inspection 577356 - 2009-04-14
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