FDA Inspection
James W. Baker, MDJames W. Baker, MD – FDA Inspection, Sep 19, 2013
Record Details
This FDA Inspection record concerns James W. Baker, MD, with an inspection on September 19, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- James W. Baker, MD
- Inspection Date
- September 19, 2013
- Product Type
- Biologics
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ID · 9bab1205-893f-4daa-87a3-f9bcd884b024
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850039
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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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 |
| June 19, 2017 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 26, 2016 | 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 1015871 - 2017-06-19
- FDA Inspection 991201 - 2016-05-26
- FDA Inspection 673849 - 2010-06-15
- FDA Inspection 577356 - 2009-04-14
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